BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 1983836 · Received February 10, 2011

    Report

    Report Number
    1020279-2011-00036
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 10, 2011
    Manufacturer
    SMITH & NEPHEW, ORTHOPEDICS
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO A BREAKAGE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FEMORAL STEM JDH SMITH & NEPHEW, ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R