FDA Adverse Event
Injury
Summary report: N
ZIMMER KNEE
MDR report key: 2003462
·
Received February 21, 2011
Report
- Report Number
- MW5019507
- Event Type
- Injury
- Date Received
- February 21, 2011
- Date of Event
- February 16, 2011
- Report Date
- February 21, 2011
- Manufacturer
- ZIMMER US, INC.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ZIMMER TOTAL KNEE REVISION WAS DONE (B)(6) 2010. A PIECE OF THE COMPONENT LOOKS TO BE DEFECTIVE AND WAS REPLACED (B)(6) 2011. THEY WERE REMOVED BY IMPLANTING SURGEON AS THEY WERE BENT/OR DEFORMED AND THOUGHT THEY WERE DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER KNEE | RIGHT KNEE REVISION NLN11 | JWH | ZIMMER US, INC. | S00585204030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Disability |