BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES

    MDR report key: 1020599 · Received March 28, 2008

    Report

    Report Number
    2648920-2008-00018
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 DURING SURGICAL PROCEDURE IN 2008, PARTS OF THE MESH FROM THE CUP WERE FALLING OFF OR UNRAVELING INTO THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES HIP PROSTHESIS KWB ZIMMER MANUFACTURING B.V. NA 60831243

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R