FDA Adverse Event
Other
Summary report: N
FOUNDATION KNEE
MDR report key: 1943844
·
Received December 22, 2010
Report
- Report Number
- 1644408-2010-00681
- Event Type
- Other
- Date Received
- December 22, 2010
- Date of Event
- December 13, 2010
- Report Date
- December 13, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JWH
- PMA / PMN Number
- K923277
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PT PRESENTED WITH EXTREME PAIN AND WAS UNSTABLE. IN SURGERY, IT WAS DETERMINED THAT THERE WAS CONSIDERABLE POLY WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION KNEE | PRIMARY STANDARD 500 SERIES INSERT | JWH | ENCORE MEDICAL, L.P. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |