FDA Adverse Event
Other
Summary report: N
FOUNDATION FEMORAL COMPONENT
MDR report key: 1220516
·
Received October 29, 2008
Report
- Report Number
- 1644408-2008-00394
- Event Type
- Other
- Date Received
- October 29, 2008
- Date of Event
- October 6, 2008
- Report Date
- October 7, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- KWY
- PMA / PMN Number
- K923277
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE POSTERIOR ASPECT OF THE FEMUR WAS EITHER WORN OFF OR BROKEN OFF, WHICH WAS CAUSING THE PATIENT'S FEMUR TO SLIDE OFF THE POSTERIOR ASPECT OF HER TIBIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION FEMORAL COMPONENT | NON-POOROUS FEMUR, SIZE 2, RIGHT | KWY | ENCORE MEDICAL, L.P. | 78211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention | 120-01-029| 350-19-102 |