BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3120447 · Received May 2, 2013

    Report

    Report Number
    3005180920-2013-00044
    Event Type
    Injury
    Date Received
    May 2, 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 2 STD - REF (B)(4)/LOT 104266 (64 STEMS PRODUCED). ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION CYCLES. SIXTY STEMS BELONGING TO THIS LOT HAVE ALREADY BEEN IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE INFECTION IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    REF IMP REPORT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193439 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 2 STD CEMENTLESS LZO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1