FDA Adverse Event
Injury
Summary report: N
BIPOLAR
MDR report key: 2396801
·
Received January 4, 2012
Report
- Report Number
- 1020279-2012-00003
- Event Type
- Injury
- Date Received
- January 4, 2012
- Date of Event
- December 19, 2011
- Report Date
- December 19, 2011
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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 | BIPOLAR | FEMORAL COMPONENT | JDH | SMITH & NEPHEW, INC. | 10DM14891 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |