BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR CUP POSITIONER

    MDR report key: 2193424 · Received July 13, 2011

    Report

    Report Number
    1822565-2011-01653
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    April 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION 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

    THE CUP POSITIONERS HAVE FRACTURED INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR CUP POSITIONER LXH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1