Multi-Center Comparative Trial of the ASR™-XL Acetabular... | NCT00561600

Label	Type	Description	Intervention Names
A	Active Comparator	ASR™-XL Modular Acetabular Cup System stem	Device: ASR™-XL Modular Acetabular Cup System
B	Active Comparator	Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.	Device: Pinnacle™ acetabular shell

Name	Type	Description	Arm Group Labels	Other Names
ASR™-XL Modular Acetabular Cup System	Device	The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter.

Measure	Description	Time Frame
Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes	"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score => 80 at 24 months"	24-month interval.

Measure	Description	Time Frame
T-Test of Harris Hip Total Score Means at 24 Months	T-Test of Harris Hip total score means at 24 months	24 months
Harris Hip Pain Sub Score at 24 Months	Mean Harris Hip Pain sub score

Name	Affiliation	Role
Dave Whalen, BS, DC	DePuy Orthopaedics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Desert Orthopaedics		Rancho Mirage	California	92270	United States
Resurgens Orthopaedics

ID	Title	Description
FG000	A ASR™-XL	ASR™-XL Modular Acetabular Cup System stem
FG001	B Pinnacle™	Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.

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

Composite Success Based Upon Harris Hip Score, Radiographic and Survivorship Outcomes

"Composite success: 1) Revision free (life of study) 2) No evidence of radiographic failure (life of study) 3) Harris Hip score => 80 at 24 months"

Out of the 265 enrolled subjects, 51 subjects were removed from the analysis for the following reasons: 2 deaths (1 inv, 1 control); 4 protocol violations (0 inv, 4 control); 6 consent withdrawn (2 inv, 4 control); 39 lost to follow-up (17 inv, 22 control).

Posted

Number

participants

24-month interval.

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG000110 OG001104

Title

Denominators

Categories

Title	Measurements
	OG00082 OG00192

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A non-inferiority test of the proportion successful for each treatment group will be the primary test of efficacy in this investigation. The null hypothesis is Ho: Xc-Xt ≥ 0.08 and the alternative hypothesis is HA:Xc-Xt < 0.08 Sample size of 126 per group was needed assuming 93% success rates, this was increased to 150 per group to account for attrition.	Chi-squared		0.872		percentage difference	.139			1-Sided	95		.225			The upper confidence limit was a priori determined to be a secondary endpoint		Non-Inferiority or Equivalence

Secondary

T-Test of Harris Hip Total Score Means at 24 Months

T-Test of Harris Hip total score means at 24 months

Posted

Mean

Standard Deviation

Units on a scale of 0-100,100 is best.

24 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG000110 OG001

Secondary

Harris Hip Pain Sub Score at 24 Months

Mean Harris Hip Pain sub score

Posted

Mean

Standard Deviation

units on scale of 0-44. 44 is best

24 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG000110 OG001

Secondary

Harris Hip Function Score at 24 Months

Mean Harris Hip Function sub score at 24 months

Posted

Mean

Standard Deviation

units on a scale 0-47. 47 is best

24 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG000110 OG001

Secondary

Analysis of Metal Ion Release - Serum Cobalt

Serum Cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

Pre-operative

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00031 OG001

Secondary

Analysis of Metal Ion Release - Serum Chromium

Serum Chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

pre-operative

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00031

Secondary

Analysis of Metal Ion Release - Erythrocyte Cobalt

Erythrocyte cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

pre-operative

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00031

Secondary

Analysis of Metal Ion Release - Erythrocyte Chromium

Erythrocyte Chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

Pre-operative

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00031

Secondary

Analysis of Metal Ion Release - Serum Cobalt

Serum Cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

4 months post-operative

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00032

Secondary

Analysis of Metal Ion Release - Serum Chromium

Serum Chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

4 months post operative

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00032

Secondary

Analysis of Metal Ion Release - Erythrocyte Cobalt

Erythrocyte Cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

4 months post-operative

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00032

Secondary

Analysis of Metal Ion Release - Erythrocyte Chromium

Erythrocyte Chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

4 months post-operative

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00032

Secondary

Analysis of Metal Ion Release - Serum Cobalt

Serum Cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

12 months post-operative

ID	Title	Description
OG000	ASR XL	ASR™-XL Acetabular Cup System
OG001	Pinnacle MoM	Pinnacle metal on metal acetabular cup system

Units	Counts
Participants	OG000

Secondary

Analysis of Metal Ion Release - Serum Chromium

Serum Chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

12 Months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00030 OG001

Secondary

Analysis of Metal Ion Release - Erythrocyte Cobalt

Erythrocyte Cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

12 Months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00030

Secondary

Analysis of Metal Ion Release - Erythrocyte Chromium

Erythrocyte Chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

12 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00030

Secondary

Analysis of Metal Ion Release - Serum Cobalt

Serum Cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

24 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00025 OG001

Secondary

Analysis of Metal Ion Release - Serum Chromium

Serum Chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

24 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00025 OG001

Secondary

Analysis of Metal Ion Release - Erythrocyte Cobalt

Erythrocyte Cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

24 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00025

Secondary

Analysis of Metal Ion Release - Erythrocyte Chromium

Erythrocyte Chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

24 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00025

Secondary

Analysis of Metal Ion Release - Serum Cobalt

Serum Cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

36 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00030 OG001

Secondary

Analysis of Metal Ion Release - Serum Chromium

Serum Chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

36 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00030 OG001

Secondary

Analysis of Metal Ion Release - Erythrocyte Cobalt

Erythrocyte cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

36 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00030

Secondary

Analysis of Metal Ion Release - Erythrocyte Chromium

Erythrocyte chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

36 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00030

Secondary

Analysis of Metal Ion Release - Serum Cobalt

Serum Cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

48 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00015 OG001

Secondary

Analysis of Metal Ion Release - Serum Chromium

Serum Chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

48 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00015 OG001

Secondary

Analysis of Metal Ion Release - Erythrocyte Cobalt

Erythrocyte Cobalt

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

48 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00013

Secondary

Analysis of Metal Ion Release - Erythrocyte Chromium

Erythrocyte chromium

Metal ion sub-study was limited to two sites. All participants with available data are presented below.

Posted

Median

Full Range

ug/L

48 months

ID	Title	Description
OG000	ASR XL Acetabular Cup System
OG001	Pinnacle Acetabular Cup System

Units	Counts
Participants	OG00013

Other Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0013 events3 affected135 at risk
Atrial flutter	Cardiac disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Cardiac failure	Cardiac disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Myocardial infarction	Cardiac disorders	MedDRA 16.0	EG0002 events2 affected130 at risk EG0011 events1 affected135 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Tachycardia	Cardiac disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Hip dysplasia	Congenital, familial and genetic disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Colitis	Gastrointestinal disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Ileus	Gastrointestinal disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 16.0	EG0002 events1 affected130 at risk EG0011 events1 affected135 at risk
Asthenia	General disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Death	General disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Device component issue	General disorders	MedDRA 16.0	EG0007 events6 affected130 at risk EG0010 events0 affected135 at risk
Device dislocation	General disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Medical device complication	General disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Medical device site reaction	General disorders	MedDRA 16.0	EG0005 events5 affected130 at risk EG0011 events1 affected135 at risk
Pain	General disorders	MedDRA 16.0	EG0004 events4 affected130 at risk EG0012 events2 affected135 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Multiple sclerosis	Immune system disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Abscess	Infections and infestations	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Cellulitis	Infections and infestations	MedDRA 16.0	EG0001 events1 affected130 at risk EG0012 events1 affected135 at risk
Infection	Infections and infestations	MedDRA 16.0	EG0001 events1 affected130 at risk EG0015 events3 affected135 at risk
Laryngitis	Infections and infestations	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Oral candidacies	Infections and infestations	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Pneumonia	Infections and infestations	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Tooth abscess	Infections and infestations	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.0	EG0001 events1 affected130 at risk EG0011 events1 affected135 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 16.0	EG0004 events3 affected130 at risk EG0011 events1 affected135 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Iliotibial band syndrome	Injury, poisoning and procedural complications	MedDRA 16.0	EG0003 events2 affected130 at risk EG0012 events2 affected135 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 16.0	EG0000 events0 affected130 at risk EG0013 events3 affected135 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 16.0	EG0002 events1 affected130 at risk EG0010 events0 affected135 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 16.0	EG0002 events2 affected130 at risk EG0010 events0 affected135 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 16.0	EG0001 events1 affected130 at risk EG0012 events2 affected135 at risk
Postoperative heterotopic calcification	Injury, poisoning and procedural complications	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 16.0	EG0003 events2 affected130 at risk EG0015 events4 affected135 at risk
Blood heavy metal increased	Investigations	MedDRA 16.0	EG0004 events4 affected130 at risk EG0010 events0 affected135 at risk
Hematocrit decreased	Investigations	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
White blood cell increased	Investigations	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Gout	Metabolism and nutrition disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0012 events1 affected135 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG00020 events9 affected130 at risk EG00115 events11 affected135 at risk
Arthralgia joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0011 events1 affected135 at risk
Back disorder	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0005 events5 affected130 at risk EG0016 events6 affected135 at risk
Bone loss	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG00019 events12 affected130 at risk EG00110 events8 affected135 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0006 events5 affected130 at risk EG0015 events3 affected135 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Joint crepitation	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Joint lock	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Muscle disorder	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0011 events1 affected135 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0003 events3 affected130 at risk EG0010 events0 affected135 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG00011 events8 affected130 at risk EG0019 events7 affected135 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0003 events2 affected130 at risk EG0011 events1 affected135 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Plantar Fascitis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Rotataor cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0002 events1 affected130 at risk EG0010 events0 affected135 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 16.0	EG0002 events2 affected130 at risk EG0012 events2 affected135 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	EG0000 events0 affected130 at risk EG0012 events2 affected135 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	EG0000 events0 affected130 at risk EG0012 events2 affected135 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	EG0002 events1 affected130 at risk EG0010 events0 affected135 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.0	EG0001 events1 affected130 at risk EG0011 events1 affected135 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Paresthesia	Nervous system disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0012 events2 affected135 at risk
Piriformis syndrome	Nervous system disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Sciatica	Nervous system disorders	MedDRA 16.0	EG0002 events2 affected130 at risk EG0010 events0 affected135 at risk
Anxiety	Psychiatric disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Chest discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0012 events1 affected135 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.0	EG0002 events2 affected130 at risk EG0010 events0 affected135 at risk
Angioplasty	Surgical and medical procedures	MedDRA 16.0	EG0001 events1 affected130 at risk EG0011 events1 affected135 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 16.0	EG0006 events5 affected130 at risk EG0013 events3 affected135 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 16.0	EG0003 events2 affected130 at risk EG0011 events1 affected135 at risk
Knee operation	Surgical and medical procedures	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Post procedural drainage	Surgical and medical procedures	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Shoulder operation	Surgical and medical procedures	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Aortic aneurysm	Vascular disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Haematoma	Vascular disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Hypertension	Vascular disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Hypotension	Vascular disorders	MedDRA 16.0	EG0002 events2 affected130 at risk EG0010 events0 affected135 at risk
Varicose vein	Vascular disorders	MedDRA 16.0	EG0000 events0 affected130 at risk EG0011 events1 affected135 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk
Adverse drug reaction	General disorders	MedDRA 16.0	EG0001 events1 affected130 at risk EG0010 events0 affected135 at risk

ID	Title	Description
BG000	ASR XL	ASR™-XL Acetabular Cup System
BG001	Pinnacle MoM	Pinnacle metal on metal acetabular cup system
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ASR XL Acetabular Cup System				0	0	72	130
EG001	Pinnacle Acetabular Cup System				0	0	59	135