BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL GLENOSPHERE DISTRACTOR

    MDR report key: 3874375 · Received April 18, 2014

    Report

    Report Number
    1822565-2014-00509
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 WHILE USING THE DISTRACTOR GUN THE SURGEON HEARD A SNAP AND NOTICED THAT THE DEVICE HAD FRACTURED AND WAS NO LONGER USABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238527 TRABECULAR METAL GLENOSPHERE DISTRACTOR HSD ZIMMER INC 61566464

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR