Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem

Newly or previously implanted subjects must meet all the following inclusion Criteria:

• Has undergone primary Total Hip Arthroscopy for any of the following:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;lnflammatory degenerative joint disease such as rheumatoid arthritis; or
• Correction of functional deformity;
• Subject is implanted with the PROFEMUR® Preserve Femoral Stem(s) and cobalt-chromium Modular Neck;
• Subject is willing and able to complete required study visits or assessments through the 10 year postoperative follow-up schedule;
• Subject is implanted with WMT or MPO head, cup and liner.

Newly or previously implanted bilateral subjects can have both Total Hip Arthroscopy enrolled in the study provided: 1) the specified PROFEMUR® Preserve Femoral Stems and cobalt-chromium Modular Necks were implanted in both, 2) all other aspects of the Inclusion/Exclusion Criteria are satisfied, 3) enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and 4) the subject agrees to a second Informed Consent document specific to the second Total Hip Arthroscopy.

Previously implanted subjects who had undergone revision of any Total Hip Arthroscopy component including the PROFEMUR® Preserve Femoral Stem(s) or, cobalt-chromium Modular Neck will also be eligible to be considered for this study.

Exclusion criteria

Subjects will be excluded if they meet any of the following criteria:

• Subjects implanted with non-MicroPort or Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners);
• Subjects implanted with a PROFEMUR® Preserve stem assembled to a Titanium Modular Neck;
• Subjects skeletally immature (less than 21 years of age) at time of primary Total Hip Arthroscopy surgery;
• Subjects have or had an overt infection at the time of implantation;
• Subjects have or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation;
• Subjects have or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at time of implantation;
• Subjects have or had inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable;
• Subject has neuropathic joints;
• Subject has hepatitis or HIV infection;
• Subject has a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing;
• Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol;
• Subjects unwilling or unable to sign the Informed Consent document;
• Subjects with documented substance abuse issues;
• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study;
• Subjects who are incarcerated or have pending incarceration.