FDA Adverse Event
Injury
Summary report: N
GII
MDR report key: 3123874
·
Received May 22, 2013
Report
- Report Number
- 1020279-2013-00274
- Event Type
- Injury
- Date Received
- May 22, 2013
- Date of Event
- May 7, 2013
- Report Date
- May 7, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FEMORAL LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226002 | GII | GII FEMORAL | JWH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |