FDA Adverse Event
Injury
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 1065917
·
Received June 25, 2008
Report
- Report Number
- 1226188-2008-00014
- Event Type
- Injury
- Date Received
- June 25, 2008
- Date of Event
- May 19, 2008
- Report Date
- June 17, 2008
- Manufacturer
- OMNI LIFE SCIENCE INX
- 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
NECK, LONG 50; CAT# 200610; LOT# 169.
Description of Event or Problem · 1
TOTAL HIP REVISION PERFORMED FOR A FAILED PIN 68 MONTHS AFTER ORIGINAL SURGERY. IT WAS REPORTED THAT THERE WAS NO COMPLICATIONS DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | KWY | OMNI LIFE SCIENCE INX | STEM 7 X 16MM | 157 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |