FDA Adverse Event
Injury
Summary report: N
OXINIUM
MDR report key: 2160454
·
Received July 13, 2011
Report
- Report Number
- 1020279-2011-00249
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- June 21, 2011
- Report Date
- July 11, 2011
- Manufacturer
- SMITH & NEPHEW, ORTHOPEDICS
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXINIUM | FEMORAL HEADS | JDH | SMITH & NEPHEW, ORTHOPEDICS | 08JM01861 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |