BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL

    MDR report key: 3253893 · Received July 23, 2013

    Report

    Report Number
    3006639916-2013-00086
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 23, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUP WOULD NOT SEAT FIRMLY IN PLACE DURING IMPACTION. ANOTHER CUP WAS IMPLANTED. REFERENCE MFR REPORT # 3005180920-2013-00086.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342346 VERSAFITCUP DM CEMENTLESS ACETABULAR SHELL ACETABULAR DOUBLE MOBILITY SHELL LZO MEDACTA INTERNATIONAL SA 124714

    Patients

    Seq Age Sex Outcome Treatment
    1 Other