FDA Adverse Event
Injury
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 1181623
·
Received September 29, 2008
Report
- Report Number
- 1226188-2008-00030
- Event Type
- Injury
- Date Received
- September 29, 2008
- Date of Event
- September 10, 2008
- Report Date
- September 25, 2008
- Manufacturer
- OMN 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 IMPLANTS REMOVED: NECK, LONG 50, CAT# 200610, LOT# 144, MFG 4/11/01, EXP 5/31/05; HEAD 28MM, CAT# 302807, LOT# 237, MFG 2/26/02, EXP 2/28/2007.
Description of Event or Problem · 1
LEFT TOTAL HIP REVISION PERFORMED DUE TO A BROKEN PIN. SURGERY PERFORMED IN 2008, 62 MONTHS AFTER PRIMARY SURGERY. IT WAS REPORTED THAT PATIENT HAD NO PROBLEMS POST SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | KWY | OMN LIFE SCIENCE, INC. | SZ 5 X 13MM | 202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |