BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE LINER STANDARD

    MDR report key: 1062610 · Received June 18, 2008

    Report

    Report Number
    1822565-2008-00337
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 THE DEVICE WAS IMPLANTED IN 2004. REVISION SURGERY OCCURRED IN 2007, DUE TO FIBROUS INGROWTH OF THE FEMORAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE LINER STANDARD HIP PROSTHESIS KWB ZIMMER, INC. NA 60125090

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R