28mm Ceramic-on-Ceramic Total Hip Replacement Study

This is a prospective, non-randomized study of the 28mm Ceramic on Ceramic (COC) device. This
study will follow each subject through 10 years postoperatively and will consist of:

1. a clinical follow-up phase and

2. a clinical outcomes phase.

Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then
annually through year 5 for each subject. For years 6 - 10, a communication will be sent to
each subject in order to collect survivorship and general health information. This
communication will ask whether the COC device is still in vivo and, if not, when the revision
surgery took place, why, and which components were removed, if applicable. In addition,
subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up
interval. A self-addressed, stamped envelope will be provided to facilitate information
return and privacy.

Inclusion Criteria:

- Subjects who were previously enrolled in the COC28 IDE study, or

- Newly recruited individuals who are qualified based on the approved labeling of the
device, and;

- Individuals who are willing and able to provide informed patient consent for
participation in the study;

- Individuals who are willing and able to return for follow-up as specified by the study
protocol; and

- Individuals who are willing and able to complete the Hip Outcomes questionnaire and
SF-12 Health Survey as specified by the study protocol

Exclusion Criteria:

- In the opinion of the Investigator, the individual does not qualify based upon
approved labeling requirements.