FDA Adverse Event
Summary report: N
NATURAL KNEE
MDR report key: 302186
·
Received October 21, 2000
Report
- Report Number
- MW1020261
- Date Received
- October 21, 2000
- Date of Event
- March 8, 1999
- Report Date
- October 20, 2000
- Manufacturer
- SULZER ORTHOPEDICS, INC.
- Product Code
- JWH
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
NATURAL KNEE COMPONENTS MFG BY SULZER ORTHOPEDICS, INC WERE INSTALLED INTO PT'S BODY AS PART OF A LEFT KNEE REPLACEMENT. PT DISCOVERED THE DEVICE HAD FAILED, CAUSING PAIN AND INJURIES. SURGERY FOLLOWED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NATURAL KNEE | KNEE IMPLANT | JWH | SULZER ORTHOPEDICS, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |