FDA Adverse Event
Other
Summary report: N
FOUNDATION KNEE
MDR report key: 1912761
·
Received November 2, 2010
Report
- Report Number
- 1644408-2010-00582
- Event Type
- Other
- Date Received
- November 2, 2010
- Date of Event
- September 16, 2010
- Report Date
- September 16, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JWH
- PMA / PMN Number
- K923277
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - PT WAS SUFFERING FROM PAIN IN THE PATELLA. THE SURGEON REWORKED THE PATELLA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION KNEE | POLY PATELLA | JWH | ENCORE MEDICAL, L.P. | 884231C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |