BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUUM, TRILOGY IT, ALLOFIT IT LINER

    MDR report key: 3172334 · Received June 5, 2013

    Report

    Report Number
    1822565-2013-00896
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    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 AFTER INSERTING THE LINER AND CONSTRAINING RING, THE HIP WAS REPOSITIONED AND AN X-RAY WAS TAKEN. THE X-RAY SHOWED THE LINER WAS NOT PROPERLY SEATED IN THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249397 CONTINUUM, TRILOGY IT, ALLOFIT IT LINER KWZ ZIMMER, INC. 61762788

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR