BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 2071175 · Received April 27, 2011

    Report

    Report Number
    1020279-2011-00144
    Event Type
    Injury
    Date Received
    April 27, 2011
    Report Date
    April 26, 2011
    Manufacturer
    SMITH & NEPHEW, ORTHOPEDICS
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FATIGUE CRACKING IS CAUSED BY THE STEM BEARING CYCLIC (I.E. REPEATED) STRESSES IN EXCESS OF THE MATERIAL ENDURANCE LIMIT FOR AN EXTENDED PERIOD OF TIME. THESE EXCESSIVE CYCLIC STRESSES MAY BE CAUSED BY ANY NUMBER OF CONDITIONS. NO MATERIAL OR MANUFACTURING DEVIATIONS WERE FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION 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 83 YR Hospitalization| R