FDA Adverse Event
Injury
Summary report: N
RESURFACING
MDR report key: 3963717
·
Received July 29, 2014
Report
- Report Number
- 1020279-2014-00463
- Event Type
- Injury
- Date Received
- July 29, 2014
- Date of Event
- July 25, 2014
- Report Date
- July 25, 2014
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 441229 | RESURFACING | GNS II RESURF PAT 35MM | JWH | SMITH & NEPHEW, INC. | 13BMO1766 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| R |