BEUDAMED
    FDA Adverse Event Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL 56

    MDR report key: 3162627 · Received June 5, 2013

    Report

    Report Number
    3006639916-2013-00064
    Date Received
    June 5, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    RECURRENT DISLOCATIONS FOLLOWING PRIMARY SURGERY, THE ACETABULAR COMPONENTS WERE REPLACED ABOUT THREE MONTHS POST-OP. REF MFR REPORT 3005180920-2013-00064.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249331 VERSAFITCUP CC TRIO ACETABULAR SHELL 56 ACETABULAR CEMENTLESS SHELL KWA MEDACTA INTERNATIONAL SA 124086

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VERSAFITCUP CC HOODED LINER, 01.26.3248HCAT,| LOT 103419| CERAMIC FEMORAL HEAD NOT MARKETED IN THE USA