FDA Adverse Event
Injury
Summary report: N
LGN CR HIGH FLEX XLPE SZ 3-4 9MM
MDR report key: 2892797
·
Received January 2, 2013
Report
- Report Number
- 1020279-2013-00002
- Event Type
- Injury
- Date Received
- January 2, 2013
- Date of Event
- December 17, 2012
- Report Date
- December 17, 2012
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO LOOSEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1306 | LGN CR HIGH FLEX XLPE SZ 3-4 9MM | LGN CR HIGH FLEX XLPE SZ 3-4 9MM | JWH | SMITH & NEPHEW, INC. | 10KM20494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| R |