FDA Adverse Event
Injury
Summary report: N
RESURFACING
MDR report key: 2904855
·
Received January 9, 2013
Report
- Report Number
- 1020279-2013-00020
- Event Type
- Injury
- Date Received
- January 9, 2013
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO A BROKEN PATELLA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11709 | RESURFACING | GNS II RESURF PAT 35MM | JWH | SMITH & NEPHEW, INC. | 08KM08453 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |