Up to five (5) sites will participate. These sites participated in the IDE study and will continue subject follow-up.
Subjects from the original IDE study (COC 36mm investigational subjects only) will be seen for a clinic visit at the time of consent (First visit at approximately 5 to 7 years post-op or 1825- 2919 days), and at minimum 8 years (2920-3649 days) , and minimum 10 years (3650-4015 days). Harris Hip evaluation, radiographic evaluation, subject hip-outcomes, and adverse event information will be collected at each visit.
If a subject is not willing or able to return for a clinical and radiographic follow-up for either the minimum 8 year evaluation or the minimum 10 year evaluation, then a telephone interview may be utilized for the purpose of determining device survivorship.
