BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM REVERSE SHOULDER GLENOSPHERE HELMET

    MDR report key: 2062105 · Received March 17, 2011

    Report

    Report Number
    1822565-2011-00649
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. HOWEVER, THE EXACT CAUSE ANALYSIS CANNOT BE DETERMINED WITH CERTAINTY. AS RETURNED, THE REVERSE HELMET HAS A FRACTURED TAB. THE HELMET HAS AN APPROXIMATE FIELD AGE OF 3 YEARS. MANUFACTURING DOCUMENTATION FOR THIS LOT HAS BEEN REVIEWED AND INDICATES THAT THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON INSERTED THE GLENOSPHERE ONTO THE BASEPLATE USING HELMET AND INSERTION ROD. UPON DISENGAGEMENT OF THE HELMET, THE RETAINING TAB FRACTURED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM REVERSE SHOULDER GLENOSPHERE HELMET LXH ZIMMER INC 60889765

    Patients

    Seq Age Sex Outcome Treatment
    1