BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC MOD PL TB WDG HEMI-10D SZ3

    MDR report key: 517190 · Received January 30, 2004

    Report

    Report Number
    1818910-2004-00094
    Event Type
    Malfunction
    Date Received
    January 30, 2004
    Date of Event
    November 17, 2003
    Report Date
    January 19, 2004
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PFC MODULAR PLUS TIBIAL WEDGE (PRODUCT CODE 86-0176) WAS PACKAGED WITH SCREWS THAT WERE TOO LONG (I.E., 0.100" (2.54 MM) LONGER THAN THE DESIGNATED SCREWS). THE WEDGE COMPONENT IS USED IN TOTAL KNEE ARTHROPLASTY IN CONJUNCTION WITH A CEMENTED PFC MODULAR TIBIAL COMPONENT. IT IS AFFIXED TO THE BASE OF THE TIBIAL TRAY IN ORDER TO PROVIDE ADEQUATE SUPPORT AND ALIGNMENT OF THE TIBIAL TRAY COMPONENT FOR PTS WHO HAVE COMPROMISED AND/OR MISSING BONE. THE WEDGE IS PACKAGED WITH TWO SCREWS THAT ARE USED TO ATTACH IT TO THE TIBIAL TRAY COMPONENT. IN THIS PARTICULAR CASE, THE PACKAGE CONTIANED SCREWS THAT WERE TOO LONG AND EXTENDED BEYOND THE BASE OF THE TIBIAL TRAY. THE CONDITION WAS NOTED PRIOR TO IMPLANTATION AND THE EVENT RESULTED IN NO INJURY OR IMPACT TO THE PT. A HEALTH HAZARD EVALUATION WAS PERFORMED AND INDICATED THAT THE WEDGE PACKAGED WITH THE LONGER SCREWS MAY CAUSE CONFUSION IN THE OPERATING ROOM, LEADING TO A POTENTIAL DELAY IN SURGICAL TIME WHILE ANOTHER WEDGE WITH THE APPROPRIATE SCREW LENGTH IS OBTAINED. ADDITIONALLY, IF THE CONDITION IS NOTED PRIOR TO IMPLANTATION, IT IS POSSIBLE THAT THE TRAY/WEDGE ASSEMBLY COULD BE INSTALLED WITH THE SCREWS PROTRUDING DISTAL TO THE WEDGE. IN THIS SITUATION, IT IS MOST LIKELY THAT THE SCREWS WOULD PROTRUDE INTO THE CEMENT MANTLE AND WOULD NOT PENETRATE THE BONE SURFACE; THEREFORE, IT IS LIKELY THAT THE INTENDED ALIGNMENT WOULD STILL BE MAINTAINED AND THAT THERE WOULD BE NO RESULTING IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC MOD PL TB WDG HEMI-10D SZ3 TOTAL KNEE REPLACEMENT JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS, INC. NA 330722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA