FDA Adverse Event
Injury
Summary report: N
REFLECTION
MDR report key: 3790457
·
Received May 5, 2014
Report
- Report Number
- 1020279-2014-00296
- Event Type
- Injury
- Date Received
- May 5, 2014
- Date of Event
- April 17, 2014
- Report Date
- April 17, 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 REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268600 | REFLECTION | FEMORAL COMPONENT | JDH | SMITH & NEPHEW, INC. | 41004700B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Hospitalization |