FDA Adverse Event
Injury
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 749014
·
Received August 9, 2006
Report
- Report Number
- 1226188-2006-00007
- Event Type
- Injury
- Date Received
- August 9, 2006
- Date of Event
- July 28, 2006
- Report Date
- August 9, 2006
- Manufacturer
- OMNI LIFE SCIENCE, INC.
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OTHER DEVICES USED: CATALOG NUMBER 200610 LONG 50 NECK. DEVICE HISTORY RECORDS FOR THE STEM ARE INTACT AND COMFORMING AND INDICATE MANUFACTURE TO SPEC.
Description of Event or Problem · 1
RIGHT HIP REVISED 3.5 YEARS AFTER TOTAL HIP ARTHROPLASTY. AT REVISION, COBALT CHROME ALIGNMENT PIN IN THE STEM WAS OBSERVED TO HAVE SHEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | KWY | OMNI LIFE SCIENCE, INC. | 5X11.5 STEM | 311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Hospitalization |