BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM RESERVE SHOULDER GLENOSPHERE HELMET

    MDR report key: 2001532 · Received January 26, 2011

    Report

    Report Number
    1822565-2011-00136
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 28, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. 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 ON BENDING LOADS PLACED ON THE TABS MAY CAUSE THIS SITUATION. THE EXACT CAUSE ANALYSIS CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION: AS RETURNED, ONE OF THE HELMET TABS HAS FRACTURED AWAY. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PORTION OF THE GLENOSPHERE HELMET FRACTURED OFF DURING IMPACTION. THE PORTION WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM RESERVE SHOULDER GLENOSPHERE HELMET SHOULDER INSTRUMENT LXH ZIMMER, INC. 61237374

    Patients

    Seq Age Sex Outcome Treatment
    1