FDA Adverse Event
Other
Summary report: N
FOUNDATION KNEE
MDR report key: 1960291
·
Received January 7, 2011
Report
- Report Number
- 1644408-2011-00015
- Event Type
- Other
- Date Received
- January 7, 2011
- Date of Event
- December 29, 2010
- Report Date
- December 29, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JWH
- PMA / PMN Number
- K933539
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PATIENT EXPERIENCED PAINFUL AND LOOSE TIBIAL INSERT AND A PAINFUL PATELLA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION KNEE | PS 500 SERIES INSERT | JWH | ENCORE MEDICAL, L.P. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | 130-03-032, LOT N/A |