BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 2823441 · Received November 8, 2012

    Report

    Report Number
    1020279-2012-00606
    Event Type
    Injury
    Date Received
    November 8, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    SMITH&NEPHEW, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FEMORAL COMPONENT LPH SMITH&NEPHEW, INC. 09DM19272

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R