BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBALT HV BONE CEMENT

    MDR report key: 1052085 · Received May 20, 2008

    Report

    Report Number
    1825034-2008-00139
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 18, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K051496
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. REVIEW OF EVENT WITH ENGINEERING FOUND DEBRIS TO LIKELY BE FROM THE BLUE THROAT TUBE WITHIN THE LIQUID POUCH. 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 A PROCEDURE IN 2007, WHERE COBALT BONE CEMENT WAS USED, TWO (2) BLUE PLASTIC PIECES OF DEBRIS DROPPED IN THE POWDER WHEN THE LIQUID WAS ADDED. ADD'L UNITS OF CEMENT FROM THE SAME LOT WERE AVAILABLE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBALT HV BONE CEMENT LOD BIOMET, INC. NA 539740

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK