FDA Adverse Event
Malfunction
Summary report: N
SOLUTION HIP FEMORAL PROSTHESIS TOTAL HIP PROSTHESIS
MDR report key: 58551
·
Received December 20, 1996
Report
- Report Number
- 1818910-1996-00094
- Event Type
- Malfunction
- Date Received
- December 20, 1996
- Report Date
- November 22, 1996
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- KWY
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE POROUS COATED FINISH IS COMING OFF THE TOTAL HIP FEMORAL PROSTHESIS THAT WAS IMPLANTED IN A PT. NO OTHER INFO WAS PROVIDED TO CO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLUTION HIP FEMORAL PROSTHESIS TOTAL HIP PROSTHESIS Implant | TOTAL HIP PROSTHESIS | KWY | DEPUY ORTHOPAEDICS, INC. | NA | 889456 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |