BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 2995253 · Received February 28, 2013

    Report

    Report Number
    3005180920-2013-00004
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 7 STD - REF 01.18.137/LOT 103226 (30 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. THE 23 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE CAUSE OF THE FRACTURE IS HIGHLY LIKELY NOT DEVICE RELATED.

    Description of Event or Problem · 1

    THE FEMUR CRACKED PROXIMALLY DURING STEM INSERTION. THE SURGEON APPLIED CERCLAGE CABLES AND INSERTED THE SAME STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86696 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 7 STANDARD CEMENTLESS LZO MEDACTA INTERNATIONAL, SA 103226

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention