BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2773668 · Received September 26, 2012

    Report

    Report Number
    3005180920-2012-00055
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 21, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 2 LAT - (B)(4) / LOT 101030 (46 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING INCLUDED WASHING AND STERILIZATION CYCLES. THE 43 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. COCR BALL HEAD 28 (K072857) - (B)(4) / LOT 100526 (60 HEADS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. THE 43 HEADS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND ON INCIDENTS HAVE BEEN REPORTED UP TO NOW. VERSAFITCUP CC TRIO LINER (K103352) - (B)(4) / LOT 100724 (25 LINERS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. ALL THE LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED DUP TO NOW. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE INFECTION IS DEVICE RELATED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 2 LATERALIZED LZO MEDACTA INTERNATIONAL SA 101030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention COCR BALL HEAD 12/14 28: (B)(4) - LOT 100526| VERSAFITCUP CC TRIO LINER: (B)(4) - LOT 100724