BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL 52

    MDR report key: 3225880 · Received July 10, 2013

    Report

    Report Number
    3005180920-2013-00078
    Event Type
    Injury
    Date Received
    July 10, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP CC TRIO CEMENTLESS SHELL 52 - REF. (B)(4) / LOT 121425 (72 CUPS PRODUCED): ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE 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. SIXTY-FIVE 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.

    Description of Event or Problem · 1

    REFERENCE IMPORTER # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317621 VERSAFITCUP CC TRIO ACETABULAR SHELL 52 ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1