FDA Adverse Event
Injury
Summary report: N
RESURFACING
MDR report key: 2973686
·
Received February 22, 2013
Report
- Report Number
- 1020279-2013-00119
- Event Type
- Injury
- Date Received
- February 22, 2013
- Date of Event
- December 11, 2012
- Report Date
- December 11, 2012
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO DISASSOCIATION OF THE PATELLA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78331 | RESURFACING | GNS II RESURF PAT 35MM | JWH | SMITH & NEPHEW, INC. | 08GM13764 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |