FDA Adverse Event
Injury
Summary report: N
PROFIX CEMENTED TIBI
MDR report key: 2822460
·
Received November 7, 2012
Report
- Report Number
- 1020279-2012-00602
- Event Type
- Injury
- Date Received
- November 7, 2012
- Date of Event
- November 6, 2012
- Report Date
- November 6, 2012
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFIX CEMENTED TIBI | PRO NON-POR TB BASE RT S3 | JWH | SMITH & NEPHEW, INC. | 03FM05685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | (B)(4) |