BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIGEN

    MDR report key: 3943774 · Received July 18, 2014

    Report

    Report Number
    1020279-2014-00435
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    July 16, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    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 DUE TO PERI-PROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421382 TRIGEN IMPLANT JDS SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R