FDA Adverse Event
Injury
Summary report: N
LEGION CR
MDR report key: 3093477
·
Received May 6, 2013
Report
- Report Number
- 1020279-2013-00249
- Event Type
- Injury
- Date Received
- May 6, 2013
- Date of Event
- April 30, 2013
- Report Date
- April 30, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO FEMORAL COMPONENT LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 197431 | LEGION CR | LGN POROUS CR FEM SZ 8R | JWH | SMITH & NEPHEW, INC. | 09GHA0034A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |