FDA Adverse Event
Injury
Summary report: N
OXINIUM FEMORAL HEAD
MDR report key: 2972184
·
Received February 21, 2013
Report
- Report Number
- 1020279-2013-00112
- Event Type
- Injury
- Date Received
- February 21, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LEG LENGTH DISCREPANCY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76099 | OXINIUM FEMORAL HEAD | HIP IMPLANT | KWY | SMITH & NEPHEW, INC. | 12LM05448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R |