BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO CUP 54

    MDR report key: 2956788 · Received January 14, 2013

    Report

    Report Number
    3005180920-2012-00101
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 14, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC TRIO CEMENTLESS CUP 54: CODE 01.26.45.0054 / LOT 122897 (66 CUPS PRODUCED) : ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. FORTY TWO CUPS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE EVENT IS HIGHLY LIKELY NOT DEVICE RELATED AND IT IS PROBABLY ASSOCIATED TO A WRONG EVALUATION OF THE SIZE OF THE CUP DURING THE SURGERY.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO CUP DISLOCATION 9 DAYS POST OP. THE SURGEON STATED THAT THE CUP WAS STABLE INTRAOPERATIVELY BUT SLIGHTLY UNDERSIZED. THE CUP, THE INLAY AND THE BALL HEAD WERE REPLACED DURING REVISION SURGERY. THE SURGEON REAMED DEEPER AND A BIGGER CUP WAS IMPLANTED, RESULTING MORE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20041 VERSAFITCUP CC TRIO CUP 54 ACETABULAR CUP CEMENTLESS LZO MEDACTA INTERNATIONAL, SA 122897

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention