BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 2042672 · Received April 6, 2011

    Report

    Report Number
    1020279-2011-00114
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 6, 2011
    Manufacturer
    SMITH & NEPHEW, ORTHOPEDICS
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R