FDA Adverse Event
Injury
Summary report: N
RELIANCE PF HIP #2/12MM
MDR report key: 1770221
·
Received July 21, 2010
Report
- Report Number
- 9616680-2010-00485
- Event Type
- Injury
- Date Received
- July 21, 2010
- Date of Event
- July 7, 2010
- Report Date
- July 7, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K970200
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "DR. REMOVED A LOOSE COMPONENT AND REPLACED IT WITH A OMNIFIT 200MM CEMENTED STEM WITH A +5 36MM C-TAPER HEAD. TRITANIUM CUP AND MULTIPLE SCREWS AND A 10DEG HOODED X3 LINER".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELIANCE PF HIP #2/12MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | D6GEM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |