FDA Adverse Event
Injury
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 1416191
·
Received July 15, 2009
Report
- Report Number
- 1226188-2009-00013
- Event Type
- Injury
- Date Received
- July 15, 2009
- Date of Event
- June 17, 2009
- Report Date
- July 14, 2009
- Manufacturer
- OMNI LIFESCIENCE, INC.
- Product Code
- KWY
- PMA / PMN Number
- K000788
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL PRODUCT EXPLANTED: CAT# 200310, DESC. NECK, SHORT +47.5, MFG. 4/19/02, EXP. 4/30/2007, LOT# 280.
Description of Event or Problem · 1
PT UNDERWENT LEFT HIP REVISION SURGERY IN 2009, DUE TO A MODULAR STEM/PIN FAILURE, AT 78 MONTHS AFTER ORIGINAL SURGERY. IT WAS REPORTED THAT THE REVISION SURGERY WENT WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | KWY | OMNI LIFESCIENCE, INC. | 3 X 10MM | 194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |