BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS FEMORAL STEM

    MDR report key: 3080661 · Received April 5, 2013

    Report

    Report Number
    3006639916-2013-00030
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO LOOSENING OF A STEM QUADRA H 5 YEARS AND 4 MONTHS POST OP. PLEASE REFERENCE MFR REPORT # 3005180920-2013-00030.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141586 QUADRA H CEMENTLESS FEMORAL STEM FEMORAL STEM SIZE 1 STANDARD JDI MEDACTA INTERNATIONAL SA 071629

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention