BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY AB ACETABULAR SYSTEM ALTERNATE BEARING SHELL INSERT

    MDR report key: 1241109 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00826
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    July 21, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 THE DEVICE WAS IMPLANTED IN 2007 AND WAS REVISED IN 2008, DUE TO THE CERAMIC LINER FRACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY AB ACETABULAR SYSTEM ALTERNATE BEARING SHELL INSERT HIP PROSTHESIS KWB ZIMMER, INC. NA 60267849

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R