FDA Adverse Event
Injury
Summary report: N
UNIVERSAL
MDR report key: 2121313
·
Received June 13, 2011
Report
- Report Number
- 1020279-2011-00197
- Event Type
- Injury
- Date Received
- June 13, 2011
- Date of Event
- May 25, 2011
- Report Date
- June 13, 2011
- Manufacturer
- SMITH & NEPHEW, ORTHOPEDICS
- 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 LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL | FEMORAL HEAD | JDH | SMITH & NEPHEW, ORTHOPEDICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |