BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET CC CRUCIATE TRAY

    MDR report key: 1052090 · Received May 20, 2008

    Report

    Report Number
    1825034-2008-00144
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    September 4, 2007
    Report Date
    September 6, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Removal / Correction Number
    Z-255-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO EVENT DETERMINED THAT LOT OF 67MM TIBIAL TRAYS WERE INADVERTENTLY INTERCHANGED WITH LOT OF 71MM TIBIAL TRAYS DURING PRODUCTION. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED; EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED. THIS REPORT FILED ON MAY 20, 2008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY PROCEDURE IN 2007, TIBIAL TRAY COMPONENT FROM PACKAGE LABELED 141232, LOT 626520, 67MM WAS POSITIONED FOR IMPLANTATION. UPON ATTEMPTED PLACEMENT OF THE POLYETHYLENE INSERT INTO THE TIBIAL TRAY, IT WAS DETERMINED THAT THE TRAY WOULD NOT ACCEPT A 67MM INSERT. A COMPATIBLE POLYETHYLENE INSERT WAS AVAILABLE AND USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET CC CRUCIATE TRAY JWH BIOMET, INC. NA 626520

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK