FDA Adverse Event
Injury
Summary report: N
BIOMET ORTHOPEDIC, INC
MDR report key: 2364818
·
Received February 22, 2008
Report
- Report Number
- 2364818
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- May 1, 2002
- Report Date
- February 9, 2007
- Manufacturer
- BIOMET ORTHOPEDIC, INC
- Product Code
- JDI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT ADMIT (B)(6) 2002 FOR TOTAL LEFT HIP REPLACEMENT. RETURNED ON (B)(6) 2005 FOR LT HIP SNAPPING TENSOR, REQUIRED BURSECTOMY AND SYNOVECTOMY. LARGE AREA OF METALLOSIS. LG TROCHANTERIC BURSITIS, EXOSTOSIS SYNOVITIS SECONDARY TO METALLOSIS. PT RETURNED (B)(6) 2006 FOR REMOVAL OF HARDWARE AND LT TOTAL HIP ARTHROPLASTY FOR TOTAL HIP REVISION DUE TO METALLOSIS. OPERATIVE REPORT: (B)(6) 2006 SUBCUTANEOUS TISSUE FOUND GRAY/BLACK MATERIAL WHICH WAS ALSO FOUND 2 MONTHS EARLIER AND REMOVED FROM TROCHANTERIC BURSA, NOW FOUND IN SYNOVIUM LINING AND ACETABULUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET ORTHOPEDIC, INC | HIP JOINT, HEAD, CUP, FEMORAL SHAFT | JDI | BIOMET ORTHOPEDIC, INC | RD118858 | 514111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |