FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEXGEN CR KNEE IMPLANT
MDR report key: 2932492
·
Received January 24, 2013
Report
- Report Number
- 1822565-2013-00155
- Event Type
- Injury
- Date Received
- January 24, 2013
- Report Date
- December 27, 2012
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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 WAS REPORTED THAT THE PATIENT IS EXPERIENCING SWELLING, SCAR TISSUE AND INABILITY TO BEND HER KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34672 | UNKNOWN NEXGEN CR KNEE IMPLANT | KNEE PROSTHESIS | JWH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |