BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIGEN FEMORAL INTRAMEDULLARY NAIL

    MDR report key: 13618319 · Received February 28, 2022

    Report

    Report Number
    13618319
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    January 31, 2022
    Report Date
    February 24, 2022
    Manufacturer
    SMITH AND NEPHEW, INC.
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    7 MONTHS AGO, PATIENT HAD SURGERY FOR RIGHT PERITROCHANTERIC FEMUR FRACTURE. INTRAMEDULLARY NAIL RIGHT PERITROCHANTERIC FEMUR FRACTURE. AFTER 7 MONTHS FROM THE DATE OF SURGERY, PATIENT RETURNED FOR RIGHT SUBTROCHANTERIC NONUNION WITH FAILED FIXATION FIR REMOVAL OF DEEP BROKEN RIGHT FEMUR HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006397 TRIGEN FEMORAL INTRAMEDULLARY NAIL NAIL, FIXATION, BONE JDS SMITH AND NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA Male