BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3120446 · Received April 26, 2013

    Report

    Report Number
    3005180920-2013-00043
    Event Type
    Injury
    Date Received
    April 26, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 3 STD - REF (B)(4)/LOT 123809 (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. FORTY SIX STEMS BELONGING TO THIS LOT HAVE ALREADY BEEN IMPLANTED AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, WE DO NOT HAVE EVIDENCE THAT THE EVENT IS DEVICE RELATED. THE SURGEON HAS ADMITTED THAT THE STEM HE SELECTED WAS PROBABLY TOO SMALL.

    Description of Event or Problem · 1

    REF IMP REPORT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182766 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 3 STD CEMENTLESS LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1