BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3120466 · Received May 2, 2013

    Report

    Report Number
    3006639916-2013-00046
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    January 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FEMUR FRACTURED AND THE STEM SUBSIDED 15 DAYS POST OP. THE REVISION SURGERY WAS PERFORMED 1 MONTH AND A HALF POST OP. DURING REVISION, THE SURGEON TOOK 1 HOUR AND A HALF TO EXTRACT THE STEM. A CERCLAGE CABLE WAS PUT AROUND THE METAPHYSIS AND A CEMENTED STEM WAS IMPLANTED. MEDACTA HAS BEEN INFORMED ON (B)(6) ONLY. REF MFR REPORT: 3005180920-2013-00046.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193451 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 0 STD CEMENTLESS LZO MEDACTA INTERNATIONAL SA 121989

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention