BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2394492 · Received December 21, 2011

    Report

    Report Number
    3005180920-2011-00066
    Event Type
    Injury
    Date Received
    December 21, 2011
    Date of Event
    October 25, 2011
    Report Date
    December 21, 2011
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDACTA (B)(4) RECEIVED INFO CONCERNING 5 CASES OF REVISIONS OF AMISTEM H IMPLANTS FROM THE SAME SURGEON ON (B)(6) 2011, ALL DUE TO FEMUR FRACTURES. MEDACTA INTERNATIONAL RECEIVED THE COMPLAINT FORMS WITH INFO ON CODES AND LOTS INVOLVED IN THE 5 CASES ON (B)(6) 2011. THE EVENTS OCCURRED DURING THE LAST YEAR AND WERE NOT INITIALLY REPORTED TO MEDACTA. THE SURGEON DECIDED TO COLLECT THEM TOGETHER AND SEND A UNIQUE FEEDBACK. WE ANALYZED THE BATCH RECORDS AND THE X-RAYS OF EACH CASE, IN PARTICULAR, FOR THIS ONE: DOCUMENT REVIEW. AMISTEM H FEMORAL STEM SIZE 4 - REF. 01.18.134/ LOT 111859 (40 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE CONFORMING TO SPECIFICATION VALID AT THE TIME OF MFG. NINETEEN STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE X-RAYS OF ALL THE CASES, IT SEEMS HIGHLY LIKELY THAT THE SURGEON MADE ALMOST THE SAME MISTAKE: BAD POSITIONING OF THE IMPLANT OR BAD CHOICE OF THE SIZE AND, BOTH COULD HAVE LED TO THE FRACTURE. MEDACTA INTERNATIONAL IS IN CONTACT WITH THE SURGEON AND CONNECTED HIM WITH OTHER MORE EXPERIENCED (B)(6) SURGEONS TO HELP HIM BETTER UNDERSTAND HOW TO PROCEED. ON THE BASIS OF THE DATA COLLECTED, A DEVICE INVOLVEMENT IS HIGHLY UNLIKELY. THE FIVE CASES ARE REPORTED WITH THE MDRS FROM 2011-00066 TO 2011-00070.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A TOTAL HIP REPLACEMENT ON (B)(6) 2011. THEN SHE HAS PAIN 10 DAYS AFTER THE SURGERY; FROM THE X-RAYS IT WAS DETECTED THAT HER FEMUR FRACTURED AFTER 37 DAYS. ON (B)(6) 2011, A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 4 STANDARD LZO MEDACTA INTERNATIONAL, SA 111859

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention