BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS MOBILE LEG POSITIONER

    MDR report key: 3716307 · Received March 6, 2014

    Report

    Report Number
    3006639916-2014-00024
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 3, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    FWX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE IN SURGERY, THE BLACK WHEEL ON THE AMIS LEG POSITIONER BEGAN TO MAKE A GRINDING NOISE AND IT WAS ALSO DIFFICULT TO LOCK INTO PLACE. AS THE DAYS PROGRESSED IT BECAME INCREASINGLY DIFFICULT TO USE THE BLACK WHEEL AND THE LOCKING MECHANISM. BY THE THIRD SURGERY, THE PT'S FOOT HAD TO BE HELD AND ROTATED MANUALLY. REFERENCE MFR REPORT # 3005180920-2014-00024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137961 AMIS MOBILE LEG POSITIONER LEG POSITIONER FOR HIP IMPLANTATION FWX MEDACTA INTERNATIONAL SA 1111566

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other