BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1953087 · Received January 7, 2011

    Report

    Report Number
    1020279-2011-00004
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 7, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, INC.
    Product Code
    HTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE BROACH BECAME STUCK IN THE FEMUR. THE FEMUR HAD TO BE CUT TO REMOVE THE BROACH AND THE FEMUR WAS SECURED WITH CABLE AND THE STEM WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY SYNERGY TAPERED BROACH SIZE 17 HTZ SMITH & NEPHEW ORTHOPAEDICS, INC. 71366317 90406496

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention