Prospective Multicenter Post Approval Study of the LPS-Fl... | NCT00854295

Label	Type	Description	Intervention Names
Post-Approval Study Group (Group 2)	Experimental	Subjects enrolled in a short-term study (5 years) consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by orthopedic surgeons experienced in primary total knee replacement. All Group 2 subjects, both unilateral and bilateral subjects, are in the same arm of the study. As part of the PAS study, these subjects were followed from Pre-operative to 5 years.	Device: NexGen LPS-Flex Mobile Bearing Knee
Investigational Device Exemption Group (Group 1)	Experimental	Subjects who were implanted with either the LPS Flex Fixed Bearing Knee (control population) or the LPS Flex Mobile Bearing Knee device during the previous Investigational Device Exemption study. As part of the PAS study, these subjects were followed from 4 years to 10 years.	Device: NexGen LPS-Flex Mobile Bearing Knee

Name	Type	Description	Arm Group Labels	Other Names
NexGen LPS-Flex Mobile Bearing Knee	Device	Total Knee Replacement	Investigational Device Exemption Group (Group 1) Post-Approval Study Group (Group 2)

Measure	Description	Time Frame
Group 2 - Total Knee Society Score (KSS)	Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.	Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year
Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss	Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."	5 year
Group 2 - Number of Subjects With Absence of Implant Revision	Revision is defined as "No intended, actual, or planned removal of any component of the knee system."	5 year
Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication	All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.	5 year
Group 1 - Total Knee Society Score (KSS)

Name	Affiliation	Role
Erin Osborn	Zimmer Biomet	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Clinical Research		Tamarac	Florida	33321	United States
Advanced Orthopaedics

ID	Title	Description
FG000	LPS Flex Mobile Unilateral Group (Group 2)	Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee.
FG001	LPS Flex Mobile Bilateral Group (Group 2)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 6, 2014

ID	Title	Description
BG000	LPS Flex Mobile Uniliteral (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
BG001	LPS Flex Mobile Bilateral (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.
BG002	LPS Flex Fixed (Group 1)	Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
BG003	LPS Flex Mobile (Group 1)	Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG000106 BG00114 BG00277 BG00369 BG004266

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Group 2 - Total Knee Society Score (KSS)

Total Knee Society Score is used to assess pain and function which is scored from 0 to 200 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.

Only subjects with an evaluable endpoint at each time frame interval were used to calculate mean and standard deviations.

Posted

Mean

Standard Deviation

score on a scale

Pre-op, 6 week, 6 month, 1 year, 2 year, 3 year, 4 year, and 5 year

ID	Title	Description
OG000	LPS Flex Mobile Unilateral Group (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
OG001	LPS Flex Mobile Bilateral Group (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.

Units	Counts
Participants	OG000106 OG00114

Title

Denominators

Categories

Pre-op

- ParticipantsOG000106
- ParticipantsOG00114

Title	Measurements
	OG00092.2± 28.5

Primary

Group 2 - Number of Subjects With Absence of Radiolucency/Bone Loss

Independent radiographic was performed on all required post-operative follow-up intervals and a detailed report was provided at the completion of the study. Each case was expected to have anteroposterio (A/P) and lateral radiographs obtained at all postoperative assessments. An independent review of the radiographs was assessed for progressive radiolucencies over time. Per the protocol, radiographic outcomes are defined as "An absence of subsidence of greater than or equal to 2 millimeters and an absence of both osteolysis and radiolucencies greater than or equal to 2 millimeters as determined by an independent radiographic reviewer."

Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.

Posted

Count of Participants

Participants

5 year

ID	Title	Description
OG000	LPS Flex Mobile Unilateral Group (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
OG001	LPS Flex Mobile Bilateral Group (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.

Primary

Group 2 - Number of Subjects With Absence of Implant Revision

Revision is defined as "No intended, actual, or planned removal of any component of the knee system."

Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.

Posted

Count of Participants

Participants

5 year

ID	Title	Description
OG000	LPS Flex Mobile Unilateral Group (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
OG001	LPS Flex Mobile Bilateral Group (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.

Units	Counts
Participants

Primary

Group 2 - Number of Subjects With Absence of Severe Knee-Related Complication

All severe knee-related complications are determined by each study investigator. A severe adverse event is any undesirable experience associated with the use of the implant in a patient that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect. A knee-related complication is an adverse event that has been classified by the investigator to have a relation to the knee.

Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.

Posted

Count of Participants

Participants

5 year

ID	Title	Description
OG000	LPS Flex Mobile Unilateral Group (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.
OG001	LPS Flex Mobile Bilateral Group (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.

Primary

Group 1 - Total Knee Society Score (KSS)

Only subjects with an evaluable endpoint at each time frame interval were used to calculate mean and standard deviations.

Posted

Mean

Standard Deviation

score on a scale

4 year, 5 year, 6 year, 8 year, and 10 year

ID	Title	Description
OG000	LPS Flex Fixed (Group 1)	Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
OG001	LPS Flex Mobile (Group 1)	Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee. Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in both knees. Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study. Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.

Primary

Group 1 - Number of Subjects With Absence of Radiolucency/Bone Loss

Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.

Posted

Count of Participants

Participants

10 year

ID	Title	Description
OG000	LPS Flex Fixed (Group 1)	Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
OG001	LPS Flex Mobile (Group 1)	Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.

Primary

Group 1 - Number of Subjects With Absence of Implant Revision

Revision is defined as "No intended, actual, or planned removal of any component of the knee system."

Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.

Posted

Count of Participants

Participants

10 year

ID	Title	Description
OG000	LPS Flex Fixed (Group 1)	Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
OG001	LPS Flex Mobile (Group 1)	Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.

Units	Counts
Participants	OG000

Primary

Group 1 - Number of Subjects With Absence of Severe Knee-Related Complication

Only subjects with an evaluable endpoint at the applicable time frame interval were used to calculate the count of participants.

Posted

Count of Participants

Participants

10 year

ID	Title	Description
OG000	LPS Flex Fixed (Group 1)	Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.
OG001	LPS Flex Mobile (Group 1)	Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ACUTE BLOOD LOSS	Vascular disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG0030 events0 affected69 at risk
ADHESIVE CAPSULITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
ALLERGIC REACTION	Immune system disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
ALZHEIMERS	Nervous system disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
ANEMIA	Vascular disorders	Systematic Assessment	EG0003 events3 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
ANKLE FRACTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
ANKLE PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
ANKLE TENDINITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
AORTIC ANEURYSM VALVE REPLACEMENT	Cardiac disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
ARTHRALGIA SHOULDER	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
BACK INJURY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0004 events4 affected106 at risk EG0010 events0 affected14 at risk EG0026 events3 affected77 at risk EG003
BENIGN MOLE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
BICEP TEAR	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
BICEP TENDON STRAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
BLADDER INCONTINENCE	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
BLISTERS	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
BREAST CANCER	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
BRONCHITITS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
BURNING IN LEGS	General disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
BURSITIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0004 events4 affected106 at risk EG0010 events0 affected14 at risk EG0022 events2 affected77 at risk EG003
BUTTOCKS BRUISE FROM FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
BUTTOCKS PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CALF PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CALF STIFFNESS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CARCINOMA	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CARDIAC ARRHYTHMIA	Cardiac disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CARPAL TUNNEL SYNDROME	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CARPOMETACARPAL ARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CATARACT SURGERY	Eye disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CELLULITIS	Infections and infestations	Systematic Assessment	EG0003 events2 affected106 at risk EG0015 events4 affected14 at risk EG0020 events0 affected77 at risk EG003
CHEST PAIN	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CHOLECYSTECTOMY	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CHONDROMALACIA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CHRONIC BRONCHITIS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected14 at risk EG0020 events0 affected77 at risk EG003
CLL	Immune system disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CONGESTIVE HEART FAILURE	Cardiac disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CONSTIPATION	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CONTACT DERMATITIS	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CREPITATION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected14 at risk EG0020 events0 affected77 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected14 at risk EG0021 events1 affected77 at risk EG003
DEGENERATIVE DISC DISEASE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
DEGENERATIVE JOINT DISEASE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0024 events4 affected77 at risk EG003
DELAY WOUND HEALING	Infections and infestations	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
DEPRESSION	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
DIMINSHED SENSATION	Nervous system disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0029 events9 affected77 at risk EG003
DISC BULGE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
DISLOCATION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
DISTAL RADIUS FRACTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected14 at risk EG0020 events0 affected77 at risk EG003
DIZZINESS	General disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
DROP FOOT	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
DRY SKIN ON KNEE	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
ELBOW PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
ELEVATED BLOOD GLUCOSE	Vascular disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
ETIOLOGY	Infections and infestations	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
FACIAL BLEEDING	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
FAILED TOTAL HIP ARTHROPLASTY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0023 events2 affected77 at risk EG003
FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
FEMUR FRACTURE FROM FALL	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
FEVER	General disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
FIBROMYALGIA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
FLEXION CONTRACTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
FLUID IN KNEE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
FOOT INJURY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
FOOT PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
GAIT ANOMOLY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
GASTRIC ULCER	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
GASTROCNEMIUS RUPTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0022 events2 affected77 at risk EG003
HAND ARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
HAND NUMBNESS	Nervous system disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
HAND OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
HAND PAIN FROM FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
HAND PARESTHESIAS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
HAND TENDON RELEASE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected14 at risk EG0020 events0 affected77 at risk EG003
HEMATOMA	Vascular disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
HERNIA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
HIP FRACTURE FROM FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
HIP OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0004 events4 affected106 at risk EG0010 events0 affected14 at risk EG0024 events4 affected77 at risk EG003
HIP PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 events8 affected106 at risk EG0012 events2 affected14 at risk EG0021 events1 affected77 at risk EG003
HIP TROCHANTERIC BURSITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected14 at risk EG0023 events3 affected77 at risk EG003
HYDROCEPHALUS	Nervous system disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
HYDROCEPHALUS	Nervous system disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
HYPOGLYCEMIA	Vascular disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected14 at risk EG0020 events0 affected77 at risk EG003
INCREASED TROPONIN	Cardiac disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
INFECTION	Infections and infestations	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
INSTABILITY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected14 at risk EG0020 events0 affected77 at risk EG003
KIDNEY CANCER	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
KNEE ANKYLOSIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
KNEE BUCKLING	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
KNEE CLICKING	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
KNEE EFFUSION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0011 events1 affected14 at risk EG0023 events3 affected77 at risk EG003
KNEE INFLAMMATION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected14 at risk EG0020 events0 affected77 at risk EG003
KNEE OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00012 events12 affected106 at risk EG0012 events2 affected14 at risk EG0024 events3 affected77 at risk EG003
KNEE PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00054 events39 affected106 at risk EG00111 events7 affected14 at risk EG00218 events15 affected77 at risk EG003
KNEE PAIN FROM FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0007 events7 affected106 at risk EG0010 events0 affected14 at risk EG0026 events6 affected77 at risk EG003
KNEE SCAR TISSUE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
KNEE STIFFNESS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00015 events14 affected106 at risk EG0011 events1 affected14 at risk EG0021 events1 affected77 at risk EG003
KNEE STRESS FRACTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
KNEE SUBLUXATION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
KNEE SWELLING	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
KNEE TENDONITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
L-4 FRACTURE FROM FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
LAXITY SOFT TISSUE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
LEG EDEMA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
LEG PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
LENS BROKE FROM CATARACTS	Eye disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
LEUKOCYTOSIS	Vascular disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
LOW H AND H IN AM HGL 8.3 H T 24.8	Vascular disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
LOW HEMOGLOBIN	Vascular disorders	Systematic Assessment	EG0003 events3 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
LOW OXYGEN LEVELS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
LUMBAR PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
LUPUS FLARE	Immune system disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected14 at risk EG0020 events0 affected77 at risk EG003
MASTECTOMY	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
MENISCUS TEAR	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0022 events2 affected77 at risk EG003
METATORSAL DISPLACEMENT	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
NEUROPATHY	Nervous system disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
NUCLEUS PULPOSIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
OSTEOLYSIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
OSTEOLYTIC CHANGES OF TIBIAL PLATEAU	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
OSTEOPENIA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
PAIN FROM FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
PATELLA CLUNK	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
PATELLA FRACTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
PERONEAL NERVE PALSY	Nervous system disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
PINCHED NERVE IN ARM AND NECK	Nervous system disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
PINCHED NERVE SHOULDER	Nervous system disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
PLANTAR FASCITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
PROSTATE CARCINOMA	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected14 at risk EG0020 events0 affected77 at risk EG003
PULMONARY EMBOLISM	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
RADIOLUCENCY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
RASH	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected14 at risk EG0020 events0 affected77 at risk EG003
REFLUX	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
RENAL INSUFFICIENCY	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
RIB FRACTURE FROM FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
ROTATOR CUFF SURGERY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
ROTATOR CUFF TEAR	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
SCIATICA	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0023 events3 affected77 at risk EG003
SHORTNESS OF BREATH	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
SHOULDER ARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
SHOULDER INJURY	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
SHOULDER PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0004 events4 affected106 at risk EG0010 events0 affected14 at risk EG0022 events2 affected77 at risk EG003
SHOULDER STITCHES AFTER FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected14 at risk EG0020 events0 affected77 at risk EG003
SI JOINT PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected14 at risk EG0020 events0 affected77 at risk EG003
SIATICA PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
SINUSITIS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
SKIN INFECTION ON INCISION	Infections and infestations	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected14 at risk EG0020 events0 affected77 at risk EG003
SNAKE BITE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
SPINAL LSP	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0024 events4 affected77 at risk EG003
SPINE ARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
SPINE NERVE ROOT IMPINGEMENTS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
SYNOVITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
TENDINITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
THIGH PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
THYROID NODULE	Endocrine disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
TIBIAL CYSTS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
TORN MENISCUS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
TOTAL HIP ARTHROPLASTY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
TOTAL KNEE ARTHROPLASTY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 events5 affected106 at risk EG0012 events2 affected14 at risk EG0020 events0 affected77 at risk EG003
TOTAL SHOULDER ARTHROPLASTY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
TRAUMATIC BRAIN INJURY	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
TRIGGER FINGER	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
TUMOR EXCISION	Infections and infestations	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
ULCER	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
URINARY RETENTION	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
VARISCOSE VEIN	Vascular disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
VASCULITIS	Vascular disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected14 at risk EG0020 events0 affected77 at risk EG003
VERTEBRAL FRACTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
WEAKNESS IN FOOT	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
WOUND DRAINAGE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
WRIST ARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
WRIST FRACTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
WRIST MASS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
WRIST PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
YELLOW DRAINAGE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003

ID	Term
D010003	Osteoarthritis
D056304	Genu Valgum
D001168	Arthritis
D010020	Osteonecrosis

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D001847	Bone Diseases
D009336	Necrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LPS Flex Mobile Unilateral (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in one knee were in the Unilateral Group.	7	106	17	106	82	106
EG001	LPS Flex Mobile Bilateral (Group 2)	Cases were enrolled into a short-term study (5 years) and consisted of cases eligible to receive the LPS-Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement. Subjects who were implanted with the study device in two knees were in the Bilateral Group.	0	14	0	14	14	14
EG002	LPS Flex Fixed (Group 1)	Subjects in this group received the LPS-Flex Fixed Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device Exemption study.	1	77	8	77	64	77
EG003	LPS Flex Mobile (Group 1)	Subjects in this group received the LPS Flex Mobile Bearing Knee implanted by an orthopedic surgeon experienced in primary total knee replacement in one knee and were enrolled in a previous Investigational Device	1	69	5	69	14	69

Term	Organ System	Assessment Type	Statistical Information
COLON CANCER	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG0030 events0 affected69 at risk
ILIAC CREST FUSION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
LUMBAR FUSION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CERVICAL FUSION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
KNEE JOINT REPLACEMENT SURGERY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
CRAINIOTOMY	Nervous system disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
TOTAL HIP JOINT REPLACEMENT	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
MYELOMA	Vascular disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
PATIENT TRIPPED AND FELL HYPERFLEXING HER KNEE AND HAD PAIN	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
DEGENERATIVE JOINT DISEASE OF RIGHT HIP	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
INCREASED SWELLING AND PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
WOUND DRAINAGE	Infections and infestations	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
PNEUMONIA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
BREAST CANCER	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
POSTERIOR DISLOCATION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
BLADDER TUMORS	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
SUPERFICIAL HEMATOMA	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
UTERINE CANCER	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
CARDIAC BYPASS	Cardiac disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0022 events2 affected77 at risk EG003
KNEE ARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
KNEE PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0022 events2 affected77 at risk EG003
HIP PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0021 events1 affected77 at risk EG003
STROKE	Cardiac disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003
TIBIAL COMPONENT LOOSENING	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected106 at risk EG0010 events0 affected14 at risk EG0020 events0 affected77 at risk EG003