BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL SHELL WITH CLUSTER HOLES

    MDR report key: 3102026 · Received May 3, 2013

    Report

    Report Number
    1822565-2013-00749
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 THREADS ON THE CUP WERE STRIPPED WHEN IMPLANTING. A NEW CUP WAS OPENED AND USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194870 TRABECULAR METAL SHELL WITH CLUSTER HOLES KWZ ZIMMER, INC. 62283302

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR