BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 4132561 · Received October 1, 2014

    Report

    Report Number
    1020279-2014-00602
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    April 7, 2014
    Report Date
    September 15, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611906 R3 FEMORAL COMPONENT JDH SMITH & NEPHEW, INC. 13FM14816

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention