BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVERGE ACETABULAR SYSTEM RIM FLARE POROUS SHELL WITH SPIKES AND SEALED SCREWHO

    MDR report key: 1200655 · Received October 17, 2008

    Report

    Report Number
    1822565-2008-00707
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    December 7, 2006
    Report Date
    September 19, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2002 AND WAS REVISED IN LATE 2006, DUE TO PAIN. LACK OF BONY INGROWTH WAS NOTED WHEN THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVERGE ACETABULAR SYSTEM RIM FLARE POROUS SHELL WITH SPIKES AND SEALED SCREWHO HIP PROSTHESIS KWB ZIMMER, INC. NA 1512377

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R