FDA Adverse Event
Injury
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 1373260
·
Received April 28, 2009
Report
- Report Number
- 1226188-2009-00008
- Event Type
- Injury
- Date Received
- April 28, 2009
- Date of Event
- April 7, 2009
- Report Date
- April 27, 2009
- Manufacturer
- OMNLIFE 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
EXPLANTED IMPLANTS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
PATIENT HAD RIGHT TOTAL HIP REVISION DUE TO A FAILED STEM/NECK PIN IN 2009, 64 MONTHS AFTER ORIGINAL SURGERY DATE OF LATE 2003. IT WAS REPORTED THAT THE SURGERY WENT WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | KWY | OMNLIFE SCIENCE, INC. | 5 X 13MM | 377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R | MFG. 11/20/02| LOT # 349| DESC |