FDA Adverse Event
Injury
Summary report: N
EMPERION
MDR report key: 4241370
·
Received November 10, 2014
Report
- Report Number
- 1020279-2014-00684
- Event Type
- Injury
- Date Received
- November 10, 2014
- Report Date
- October 24, 2014
- 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 WAS REPORTED DUE TO A FRACTURE OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723939 | EMPERION | FEMORAL COMPONENT | JDH | SMITH & NEPHEW, INC. | 09BM20822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |