FDA Adverse Event
Injury
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 1067645
·
Received June 30, 2008
Report
- Report Number
- 1226188-2008-00016
- Event Type
- Injury
- Date Received
- June 30, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 27, 2008
- Manufacturer
- OMNI LIFE SCIENCE INC.
- Product Code
- KWY
- PMA / PMN Number
- K000788
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OTHER IMPLANT: 200310 NECK, SHORT +47.5, LOT # 241.
Description of Event or Problem · 1
HIP REVISION SURGERY FOR A BROKEN STEM PIN PERFORMED IN 2008, 72 MONTHS AFTER INITIAL THA. IT WAS REPORTED THAT THE CASE WAS UNEVENTFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | KWY | OMNI LIFE SCIENCE INC. | SZ 4 X 11.5 STEM | 204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |