BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3011038 · Received March 11, 2013

    Report

    Report Number
    3005180920-2013-00013
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    December 22, 2011
    Report Date
    March 11, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 MEDACTA RECEIVED INFORMATION CONCERNING 9 CASES OF BONE FRACTURES IN WHICH AMISTEM H IMPLANTS ARE INVOLVED, ALL REPORTED BY THE SAME SURGEON. THE COMPLETE COMPLAINT FORMS WITH INFORMATION ON CODES AND LOTS INVOLVED IN THE (B)(4) CASES WERE RECEIVED ON (B)(4) 2013. THE EVENTS OCCURRED DURING THE YEARS 2010-2011-2012 AND WERE NOT INITIALLY REPORTED TO MEDACTA. THE SURGEON DECIDED TO COLLECT THEM TOGETHER AND SEND A UNIQUE FEEDBACK. DOCUMENT REVIEW: WE ANALYZED THE BATCH RECORDS OF EACH CASE, IN PARTICULAR, FOR THIS ONE: AMISTEM H FEMORAL STEM SIZE 3 - REF. 01.18.133 / LOT 112641 (40 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THE 37 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM A DISCUSSION BETWEEN THE SURGEON AND MEDACTA, IT SEEMED THAT THE SURGEON WAS NOT CONFIDENT WITH THE SURGICAL TECHNIQUE AND THE CHOICE OF THE IMPLANTS AND BOTH THESE FACTORS ARE HIGHLY LIKELY THE CAUSES OF THE FRACTURES. MEDACTA INTERNATIONAL IS IN CONTACT WITH THE SURGEON AND CONNECTED HIM WITH TWO MORE EXPERT SWISS SURGEONS TO HELP HIM BETTER UNDERSTANDING HOW TO PROCEED. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IS HIGHLY UNLIKELY. THE NINE CASES ARE REPORTED WITH THE MDRS FROM 2013-00011 TO 2013-00019.

    Description of Event or Problem · 1

    PERIPROSTHETIC FRACTURE 2 WEEKS POST-OPERATIVELY FOLLOWING AMIS STEM HIPS. SITE OF FRACTURE: SHAFT. REVISION SURGERY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102535 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 STD CEMENTLESS LZO MEDACTA INTERNATIONAL SA 112641

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention