FDA Adverse Event
Other
Summary report: N
3D KNEE
MDR report key: 1880549
·
Received October 19, 2010
Report
- Report Number
- 1644408-2010-00553
- Event Type
- Other
- Date Received
- October 19, 2010
- Date of Event
- September 20, 2010
- Report Date
- September 20, 2010
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JWH
- PMA / PMN Number
- K020114
- 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'S KNEE WAS ASPIRATED DUE TO (B)(6) GROWING OUT OF THE ASPIRATION. AFTER CLEANING UP THE INFECTED AREA, SURGEON PERFORMED A POLY SWAP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3D KNEE | TIBIAL INSERT | JWH | ENCORE MEDICAL, L.P. | 433202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |