FDA Adverse Event
Injury
Summary report: N
UNKNOWN ZIMMER PATELLA
MDR report key: 1960991
·
Received January 11, 2011
Report
- Report Number
- 1822565-2011-00027
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- December 8, 2010
- Report Date
- December 8, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED FOR PAIN. AFTER EXPOSURE, THE PATELLA WAS FOUND TO BE LOOSE AND FREE-FLOATING WITHIN THE JOINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN ZIMMER PATELLA | KNEE PROSTHESIS | JWH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |