FDA Adverse Event
Injury
Summary report: N
UNK PHK ARTICULAR SURFACE
MDR report key: 4317094
·
Received December 4, 2014
Report
- Report Number
- 1822565-2014-01691
- Event Type
- Injury
- Date Received
- December 4, 2014
- Date of Event
- October 29, 2014
- Report Date
- November 5, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
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 DUE TO MIGRATION OF THE ARTICULAR SURFACE HINGE PIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 784644 | UNK PHK ARTICULAR SURFACE | KNEE PROSTHESIS | JWH | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |