BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR LINER INSERTER

    MDR report key: 2150571 · Received June 22, 2011

    Report

    Report Number
    1822565-2011-01473
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS REPORTED THAT THE HANDLE FRACTURED WHEN IMPACTING THE LINER. SOME FRAGMENTS FELL IN THE WOUND, BUT WERE REMOVED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR LINER INSERTER LXH ZIMMER, INC. 60440663

    Patients

    Seq Age Sex Outcome Treatment
    1