BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HCPII ACETABULAR COMPONENT LONGEVITY CROSSLINKED POLYETHYLENE LINER STANDARD

    MDR report key: 1062612 · Received June 18, 2008

    Report

    Report Number
    1822565-2008-00339
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    November 20, 2007
    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 LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HCPII ACETABULAR COMPONENT LONGEVITY CROSSLINKED POLYETHYLENE LINER STANDARD HIP PROSTHESIS KWB ZIMMER, INC. NA 94000087

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R