FDA Adverse Event
Injury
Summary report: N
INTERFIT
MDR report key: 1914516
·
Received December 3, 2010
Report
- Report Number
- 1020279-2010-00345
- Event Type
- Injury
- Date Received
- December 3, 2010
- Date of Event
- October 25, 2010
- Report Date
- November 5, 2010
- Manufacturer
- SMITH & NEPHEW, ORTHOPAEDICS
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE METAL TRANSFER ON THE FEMORAL HEAD MAY HAVE BEEN DUE TO CONTACT WITH METAL DEBRIS THAT MAY HAVE BEEN TRAPPED BETWEEN THE ARTICULATING SURFACES.
Description of Event or Problem · 1
REVISION SURGERY WAS REPORTED DUE TO A BROKEN CERAMIC LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERFIT | LINER | JDI | SMITH & NEPHEW, ORTHOPAEDICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |