FDA Adverse Event
Injury
Summary report: N
REFLECTION
MDR report key: 3863951
·
Received June 10, 2014
Report
- Report Number
- 1020279-2014-00357
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- May 13, 2014
- Report Date
- May 30, 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 SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339036 | REFLECTION | FEMORAL COMPONENT | JDH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |