FDA Adverse Event
Injury
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 1367971
·
Received April 21, 2009
Report
- Report Number
- 1226188-2009-00007
- Event Type
- Injury
- Date Received
- April 21, 2009
- Date of Event
- March 24, 2009
- Report Date
- April 21, 2009
- Manufacturer
- OMNI 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
ADDITIONAL PRODUCT EXPLAINED: CAT# 220610, DESC. NECK LONG, 50, MFG. 11/20/02, EXP. 11/2007 LOT# 349. PRODUCT 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, 65 MONTHS AFTER ORIGINAL SURGERY DATE OF 2003. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE POST SURGERY. (2009).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | KWY | OMNI LIFE SCIENCE, INC. | SZ 5 X 13MM | 377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |