FDA Adverse Event
Other
Summary report: N
FOUNDATION KNEE
MDR report key: 1853236
·
Received September 30, 2010
Report
- Report Number
- 1644408-2010-00515
- Event Type
- Other
- Date Received
- September 30, 2010
- Date of Event
- September 21, 2010
- Report Date
- September 21, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JWH
- PMA / PMN Number
- K923277
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PT HAD A KNEE INFECTION, THE SURGEON REMOVED THE ANTIBIOTIC SPACER AND INSERTED NEW DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FOUNDATION KNEE | PRIMARY INSERT, 500 SERIES | JWH | ENCORE MEDICAL, L.P. | 53867058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |