FDA Adverse Event
Malfunction
Summary report: N
AMK CEM FIX STEM TIB TRAY
MDR report key: 382824
·
Received March 15, 2002
Report
- Report Number
- 1818910-2002-00133
- Event Type
- Malfunction
- Date Received
- March 15, 2002
- Report Date
- March 15, 2002
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE TIBIAL PIN INCLUDED WITH THIS ITEM DID NOT FIR THE TRAY. AS THE TRAY WAS ALREADY CEMENTED IN; THEY OPENED UP TWO (2) MORE BOXES TO SEE IF ANOTHER WOULD FIT; BUT TO NO AVAIL. CONSEQUENTLY; THEY USED THE TRIAL PIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMK CEM FIX STEM TIB TRAY | TOTAL KNEE PROSTHESIS | JWH | DEPUY ORTHOPAEDICS, INC. | NA | VR8CL1012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |