BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE BIPOLAR MOD. ARCOM LINER

    MDR report key: 1051544 · Received May 16, 2008

    Report

    Report Number
    1825034-2008-00125
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    November 7, 2006
    Report Date
    November 8, 2006
    Manufacturer
    BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K002998
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER, EVAL OF RETURNED DEVICE FOUND IMPLANT TO BE OUT OF DESIGN SPEC. 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 SHOULDER ARTHROPLASTY IN 2006, WHEN BI-POLAR COMPONENTS WERE ASSEMBLED, THE MODULAR HEAD COMPONENT DID NOT ARTICULATE FREELY IN THE POLYETHYLENE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABSOLUTE BIPOLAR MOD. ARCOM LINER KWT BIOMET, INC. NA 218520

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK