Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Inclusion Criteria:

• Has undergone revision total hip arthroplasty
• Subject is implanted with the specified combination of components
• Subject is willing and able to complete required study visits or assessments

Exclusion Criteria:

• Subjects currently enrolled in another clinical study
• Subjects unwilling to sign the Informed Consent document
• Subjects with substance abuse issues
• Subjects who are incarcerated or have pending incarceration