FDA Adverse Event
Injury
Summary report: N
GII
MDR report key: 3932992
·
Received July 14, 2014
Report
- Report Number
- 1020279-2014-00421
- Event Type
- Injury
- Date Received
- July 14, 2014
- Date of Event
- June 19, 2014
- Report Date
- July 3, 2014
- Manufacturer
- SMITH&NEPHEW, INC
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PEFORMED. THE CAUSE OF THE REVISION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410682 | GII | FEMORAL COMPONENT | JWH | SMITH&NEPHEW, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |