BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL GLENOSPHERE HELMET

    MDR report key: 2043174 · Received February 24, 2011

    Report

    Report Number
    1822565-2011-00398
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 28, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THIS TYPE OF FAILURE MAY OCCUR IF THE HELMET IS REMOVED FROM THE GLENOSPHERE IN A MANNER NOT CONSISTENT WITH THE METHOD DESCRIBED IN THE SURGICAL TECHNIQUE. THE INSTRUMENT IS DESIGNED TO HOLD THE GLENOSPHERE SECURELY VIA THE TABS. EXCESSIVE IMPACT OR BENDING LOADS PLACED ON THE TABS MAY CAUSE THIS SITUATION. THE EXACT CAUSE ANALYSIS CANNOT BE DETERMINED WITH CERTAINTY. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    TAB OF INSTRUMENT BROKE WHILE TRYING TO INSERT THE GLENOSPHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL GLENOSPHERE HELMET LXH ZIMMER, INC. 61145917

    Patients

    Seq Age Sex Outcome Treatment
    1