BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 STD

    MDR report key: 4143535 · Received August 21, 2014

    Report

    Report Number
    3006639916-2014-00111
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY 4.5 YEARS AFTER PRIMARY DUE TO ASEPTIC LOOSENING OF THE STEM. MFR REF# 3005180920-2014-00111.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504989 AMISTEM H FEMORAL CEMENTLESS STEM SIZE 4 STD FEMORAL CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 091145

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention