BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEM

    MDR report key: 3120464 · Received May 3, 2013

    Report

    Report Number
    3006639916-2013-00048
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    January 15, 2013
    Report Date
    May 3, 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 FRACTURE IN PER OP, DURING INSERTION OF THE STEM AMISTEM H SIZE 0; CERCLAGE CABLE NECESSARY. MEDACTA HAS BEEN INFORMED ON (B)(6) ONLY. REF MFR REPORT: 3005180920-2013-00048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195142 AMISTEM H FEMORAL STEM FEMORAL STEM SIZE 0 STD CEMENTLESS LZO MEDACTA INTERNATIONAL SA 122916

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention