FDA Adverse Event
Other
Summary report: N
FOUNDATION KNEE SYSTEM
MDR report key: 1202769
·
Received October 13, 2008
Report
- Report Number
- 1644408-2008-00357
- Event Type
- Other
- Date Received
- October 13, 2008
- Date of Event
- September 23, 2008
- Report Date
- September 23, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JWH
- PMA / PMN Number
- K923277
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - CEMENTED METAL BACKED BASEPLATE SUBSIDED AND BECAME LOOSE AND PAINFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION KNEE SYSTEM | BASEPLATE, METAL BACKED STEM | JWH | ENCORE MEDICAL, L.P. | 53783718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | 385-11-502 |