BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL 58

    MDR report key: 3080749 · Received April 8, 2013

    Report

    Report Number
    3006639916-2013-00031
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 10, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION 16 MONTHS POST OP. ALL IMPLANTS REMOVED. PLEASE REF MFR REPORT #3005180920-2013-00031.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144405 VERSAFITCUP CC TRIO ACETABULAR SHELL 58 ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 111806

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention VERSAFITCUP CC LINER: 01.26.3648HCT, LOT 104598| QUADRA H CEMENTLESS STEM: 01.12.034, LOT 100018