FDA Adverse Event
Malfunction
Summary report: N
TOTAL KNEE IMPLANTS
MDR report key: 252399
·
Received November 30, 1999
Report
- Report Number
- 1832656-1999-00004
- Event Type
- Malfunction
- Date Received
- November 30, 1999
- Date of Event
- July 23, 1999
- Report Date
- August 16, 1999
- Manufacturer
- BIOPRO, INC.
- Product Code
- JWH
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
STATES FAILED IMPLANT. REPLACED TIBIAL TRAY, AND POLY INSERT, PATELLA, AND SCREWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | Implant | TOTAL KNEE IMPLANTS | JWH | BIOPRO, INC. | NA | M032220, M034210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |