FDA Adverse Event
Injury
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 819561
·
Received February 19, 2007
Report
- Report Number
- 1226188-2007-00003
- Event Type
- Injury
- Date Received
- February 19, 2007
- Date of Event
- February 13, 2007
- Report Date
- February 19, 2007
- Manufacturer
- OMNI LIFE SCIENCE, INC.
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
OTHER DEVICES USED: CATALOG NUMBER 200310 APEX MODULAR SHORT+47.5 NECK AND CATALOG NUMBER 302807 28+7 COCR FEMORAL HEAD, MANUFACTURING LOT NUMBERS UNKNOWN.
Description of Event or Problem · 1
POROUS FEMORAL STEM REVISED 5 YEARS, 2 MONTHS AFTER PRIMARY TOTAL HIP ARTHROPLASTY. AT REVISION SURGERY, IT WAS OBSERVED THAT THE COBALT CHROME ALIGNMENT PIN IN THE MODULAR FEMORAL STEM HAD SHEARED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | JDI | OMNI LIFE SCIENCE, INC. | 5X14.5 STEM | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |