BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TM REVERSE GLENSPHERE HELMET

    MDR report key: 3151343 · Received May 30, 2013

    Report

    Report Number
    1822565-2013-00877
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 2, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TAB FRACTURED WHEN TRYING TO PLACE THE GLENOSPHERE HELMET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237620 TM REVERSE GLENSPHERE HELMET LXH ZIMMER, INC. 61972672

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR