BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3162702 · Received June 5, 2013

    Report

    Report Number
    3005180920-2013-00062
    Event Type
    Injury
    Date Received
    June 5, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, MEDACTA COLLECTED INFORMATION CONCERNING SIX CASES OF BONE FRACTURES IN WHICH ITS STEMS ARE INVOLVED. ALL OCCURRED TO THE SAME SURGEON DURING A CLINICAL STUDY. THE EVENTS OCCURRED DURING THE YEARS 2009, 2010, 2011, 2012 AND WERE NOT INITIALLY REPORTED TO MEDACTA AS COMPLAINTS. DOCUMENT REVIEW: WE ANALYZED THE BATCH RECORDS OF EACH CASE, IN PARTICULAR FOR THIS ONE: AMISTEM H FEMORAL STEM SIZE 3 - (B)(4)/LOT 093011 (60 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. FIFTY-FOUR STEMS BELONGING TO THIS LOT HAVE ALREADY BEEN IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. ON THE BASIS OF THE DATA COLLECTED, THERE IS NO EVIDENCE THAT THE EVENT IS DEVICE RELATED, BUT IT CAN BE MORE RELATED TO SURGICAL MISTAKES. THE SIX CASES ARE REPORTED WITH THE MDR'S FROM 2013-00057 TO 2013-00062.

    Description of Event or Problem · 1

    REF IMP REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248799 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 STD CEMENTLESS LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1