BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANGUARD DCM PS TIBIAL BEARING

    MDR report key: 1051549 · Received May 16, 2008

    Report

    Report Number
    1825034-2008-00119
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    April 24, 2006
    Report Date
    May 10, 2006
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K023546
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. OTHER, EVAL OF RETURNED DEVICE FOUND DIMENSIONAL NONCONFORMANCE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY PROCEDURE IN 2006, THE TIBIAL BEARING WOULD NOT SNAP INTO THE TIBIAL TRAY CORRECTLY. IMPLANT WAS REMOVED AND ANOTHER ONE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANGUARD DCM PS TIBIAL BEARING JWH BIOMET, INC. NA 012060

    Patients

    Seq Age Sex Outcome Treatment
    1