BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL 50

    MDR report key: 3233318 · Received July 12, 2013

    Report

    Report Number
    3005180920-2013-00080
    Event Type
    Injury
    Date Received
    July 12, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC TRIO CEMENTLESS SHELL 50 - REF. (B)(4), LOT 123588 (71 CUPS PRODUCED): ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE WASHING CYCLE AND THE STERILIZATION CYCLE HAVE BEEN PERFORMED ACCORDING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. FIFTY THREE SHELLS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED BUT IT IS LIKELY DUE TO A SURGICAL MISTAKE DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    REF. IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323698 VERSAFITCUP CC TRIO ACETABULAR SHELL 50 ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1