BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 2031429 · Received March 28, 2011

    Report

    Report Number
    1020279-2011-00098
    Event Type
    Injury
    Date Received
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    SMITH AND NEPHEW, ORTHOPAEDICS
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. THE ACTUAL IMPLANT WAS DISPOSED. THE SURGEON DID NOT FAULT THE DEVICE, BUT CONTRIBUTED THE REVISION TO OBESITY AND POOR BONE STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON HIP STEM JDH SMITH AND NEPHEW, ORTHOPAEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1