BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 2160455 · Received July 13, 2011

    Report

    Report Number
    1020279-2011-00248
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 11, 2011
    Manufacturer
    SMITH AND NEPHEW, INC.
    Product Code
    LPH
    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 A REVISION SURGERY WAS PERFORMED DUE TO STEM BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON HIP STEM LPH SMITH AND NEPHEW, INC. 10JM06687

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R