FDA Adverse Event
Other
Summary report: N
FOUNDATION KNEE
MDR report key: 1961706
·
Received January 11, 2011
Report
- Report Number
- 1644408-2011-00027
- Event Type
- Other
- Date Received
- January 11, 2011
- Date of Event
- December 15, 2010
- Report Date
- December 15, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JWH
- PMA / PMN Number
- K933539
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE INSERT POST WAS BROKEN. A FRAGMENT OF THE POLY WAS TRAPPED BETWEEN THE FEMUR AND THE INSERT. WEAR ON THE INSERT WAS OBSERVED DURING THE REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION KNEE | PS SERIES 500 INSERT | JWH | ENCORE MEDICAL, L.P. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LOT N/A| (B)(4) |