FDA Adverse Event
Other
Summary report: N
FOUNDATION KNEE SYSTEM
MDR report key: 1220524
·
Received October 29, 2008
Report
- Report Number
- 1644408-2008-00386
- Event Type
- Other
- Date Received
- October 29, 2008
- Date of Event
- October 22, 2007
- Report Date
- May 30, 2008
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- HSH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REVISION SURGERY - RIGHT KNEE FEMUR, FEMORAL STEM, EXTENSION, PATELLA, TIBIAL INSERT, AND TIBIAL BASEPLATE. X-RAYS CONFIRM A LOOSE TIBIAL COMPONENT, A LATERALLY SUBLUXATED PATELLA WITH CONSIDERABLE BONY EROSION FROM THE LATERAL FEMORAL CONDYLE AND THE FEMORAL COMPONENT ALSO APPEARED TO HAVE SOME LOOSENESS. ENCORE FIRST BECAME AWARE OF THE REVISION SURGERY ON (B) (6) 2008. DUE TO AN INTERNAL MISCOMMUNICATION, THE CORRECT DEPARTMENT WAS NOT NOTIFIED OF THE REVISION SURGERY UNTIL (B) (6) 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION KNEE SYSTEM | TIBIAL BASEPLATE, NONPOROUS | HSH | ENCORE MEDICAL, L.P. | 250771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention | 206-01-008/162111A| 120-01-035/270941| 370-15-010/214561| 220-15-022/203281 |