FDA Adverse Event
Injury
Summary report: N
LEGION
MDR report key: 1912583
·
Received December 2, 2010
Report
- Report Number
- 1020279-2010-00338
- Event Type
- Injury
- Date Received
- December 2, 2010
- Date of Event
- November 11, 2010
- Report Date
- December 2, 2010
- Manufacturer
- SMITH-NEPHEW INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO KNEE INSTABILITY. PRIMARY SURGERY WAS PERFORMED IN 2009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEGION | KNEE IMPLANT | JWH | SMITH-NEPHEW INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |