FDA Adverse Event
Injury
Summary report: N
AGC-S MOD. TIB. BEARING
MDR report key: 266638
·
Received February 29, 2000
Report
- Report Number
- 1825034-2000-00009
- Event Type
- Injury
- Date Received
- February 29, 2000
- Date of Event
- November 30, 1999
- Report Date
- February 28, 2000
- Manufacturer
- BIOMET, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
TOTAL KNEE ARTHROPLASTY PERFORMED 1994. REVISION PERFORMED 1999, DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AGC-S MOD. TIB. BEARING | PROSTHESIS, KNEE, COMP | JWH | BIOMET, INC. | NA | 085590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |