FDA Adverse Event
Injury
Summary report: N
UNK ROTATING HINGE KNEE IMPLANT
MDR report key: 4252937
·
Received November 12, 2014
Report
- Report Number
- 1822565-2014-01567
- Event Type
- Injury
- Date Received
- November 12, 2014
- Report Date
- October 14, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 BY THE PT'S COUNSEL THAT THE PT IS ALLEGING HARM CAUSED BY THE DEVICE; HOWEVER, THE NATURE OF THE HARM IS UNK AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729564 | UNK ROTATING HINGE KNEE IMPLANT | KNEE PROSTHESIS | JWH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |