BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS

    MDR report key: 3931658 · Received July 14, 2014

    Report

    Report Number
    9613369-2014-00078
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SMITH&NEPHEW, INC
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411121 PLUS FEMORAL COMPONENT JDG SMITH&NEPHEW, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R