BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY POLYETHYLENE LINER

    MDR report key: 1960989 · Received January 11, 2011

    Report

    Report Number
    1822565-2011-00035
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 15, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE LINER WOULD NOT LOCK INTO THE CUP. SURGERY WAS PROLONGED BY 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY POLYETHYLENE LINER HIP PROSTHESIS KWB ZIMMER, INC. 61463095

    Patients

    Seq Age Sex Outcome Treatment
    1