FDA Adverse Event
Injury
Summary report: N
ZIRCONIA
MDR report key: 1941493
·
Received December 29, 2010
Report
- Report Number
- 1020279-2010-00372
- Event Type
- Injury
- Date Received
- December 29, 2010
- Report Date
- December 29, 2010
- Manufacturer
- SMITH & NEPHEW, ORTHOPEDICS
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIRCONIA | FEMORAL HEAD | JDH | SMITH & NEPHEW, ORTHOPEDICS | 71004835 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |