Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
DePuy Orthopaedics
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Able to (or capable of) provide written, voluntary consent to participate in the clinical investigation
2. Is willing and able to return for all protocol defined clinic visits
3. Subject has a combination of the following implants in the study hip (unless in pre-op cohort):
1. Pinnacle acetabular shell with or without Gription TM porous coating
2. M-specification cobalt-chrome femoral head or aSphere M-specification cobalt-chrome femoral head
3. Ultamet metal insert
4. One of the following stems
i. S-ROM ii. Corail iii. Tri-Lock iv. AML v. Summit vi. Prodigy vii. C-Stem
4. Subject has high quality films available for review that were taken within 12 months of the primary surgery of the following views:
1. Standing AP-Pelvis
2. Standing AP-Proximal Femur (if this view is not available but the AP-Pelvis shows the entire implant and greater trochanter, that is also acceptable)
1. The subject refuses to allow their medical records to be inspected by the Sponsor, representatives of the Sponsor, the medical office staff and/or representatives from FDA
2. The implanted hip components in the study hip (exclusive of cement), are not all DePuy components (unless in pre-op cohort)
3. The primary procedure occurred greater than 8 (eight) years ago (unless in pre-op cohort)
4. FOR PRE-OPERATIVE COHORT ONLY: the subject has a MoM contralateral hip
5. FOR PRE-OPERATIVE COHORT ONLY: the subject is undergoing a revision of the Ipsilateral hip
Clareo Health | Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study
