FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 2469406
·
Received February 27, 2012
Report
- Report Number
- 1020279-2012-00112
- Event Type
- Injury
- Date Received
- February 27, 2012
- Date of Event
- February 9, 2012
- Report Date
- February 9, 2012
- Manufacturer
- SMITH & NEPHEW, INC
- Product Code
- JDH
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | FEMORAL COMPONENT | JDH | SMITH & NEPHEW, INC | 11HM13343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R |