FDA Adverse Event
Injury
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 1140965
·
Received August 28, 2008
Report
- Report Number
- 1226188-2008-00025
- Event Type
- Injury
- Date Received
- August 28, 2008
- Date of Event
- July 10, 2008
- Report Date
- August 17, 2008
- Manufacturer
- OMNI LIFE SCIENCE, INC
- Product Code
- LPH
- PMA / PMN Number
- K000788
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL OMNI IMPLANT EXPLANTED: NECK, LONG 50, CAT# 200610, LOT# 022, MFG 4/6/2000, EXP 5/30/2002.
Description of Event or Problem · 1
PT HAD LEFT TOTAL HIP ARTHROPLASTY IN LATE 2001. REVISION SURGERY PERFORMED AFTER 79 MONTHS DUE TO BROKEN STEM/NECK PIN IN 2008. IT WAS REPORTED THAT THE CASE WENT WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | LPH | OMNI LIFE SCIENCE, INC | SZ 6 X 14.5MM | 069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |