FDA Adverse Event
Injury
Summary report: N
P.F.C FLUT TIB ROD 115X14MM
MDR report key: 644816
·
Received November 4, 2005
Report
- Report Number
- 1818910-2005-02512
- Event Type
- Injury
- Date Received
- November 4, 2005
- Date of Event
- June 23, 2003
- Report Date
- October 11, 2005
- Manufacturer
- DEPUY RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PATIENT CALLED TO REPORT THAT SHE WAS IMPLANTED WITH A DEPUY KNEE IN 5/9/1994 AND ON 6/23/2003 WAS REVISED FOR POLYWEAR. THE REPLACEMENT TIBIAL COMPONENT HAS A STEM EXTENSION AND IT IS LOOSE. THE PATIENT NEEDS A SECOND REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | P.F.C FLUT TIB ROD 115X14MM | TOTAL KNEE PROSTHESIS | JWH | DEPUY RAYNHAM A DIVISION OF DEPUY ORTHOPAEDICS, INC | NA | 316117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |