BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 3022029 · Received March 26, 2013

    Report

    Report Number
    1020279-2013-00179
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 18, 2013
    Manufacturer
    SMITH&NEPHEW, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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
    124455 ECHELON ECH POR STR 15MM CAL SZ 11 LPH SMITH&NEPHEW, INC. 11LM15096

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R