FDA Adverse Event
Malfunction
Summary report: N
BIOMET
MDR report key: 2213814
·
Received June 26, 2007
Report
- Report Number
- MW5021743
- Event Type
- Malfunction
- Date Received
- June 26, 2007
- Date of Event
- May 17, 2007
- Report Date
- August 26, 2007
- Manufacturer
- BIOMET
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DJD - END STAGE OA. LEFT TIBIAL COMPONENT LOOSENING. REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET | LEFT KNEE | JWH | BIOMET | TIBIAL PLATES/ FEMCOMPONENT | 983750/972650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |