FDA Adverse Event
Injury
Summary report: N
CERAMIC
MDR report key: 1832780
·
Received September 13, 2010
Report
- Report Number
- 1020279-2010-00261
- Event Type
- Injury
- Date Received
- September 13, 2010
- Report Date
- August 13, 2010
- Manufacturer
- SMITH & NEPHEW, INC. BROOKS ROAD
- Product Code
- LPF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CERAMIC | LINER | LPF | SMITH & NEPHEW, INC. BROOKS ROAD | 04MM07850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |