BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 LAT

    MDR report key: 3870151 · Received May 23, 2014

    Report

    Report Number
    3006639916-2014-00060
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS COMPLAINING OF PAIN AND THE SURGEON DETERMINED IT WAS DUE TO THE STEM LOOSENING. THE STEM AND HEAD WERE REPLACED DURING A REVISION SURGERY. REFERENCE MFR # 3005180920-2014-00060.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308638 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 LAT FEMORAL CEMENTLESS STEM KWY MEDACTA INTERNATIONAL SA 111239

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention