BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4254864 · Received November 7, 2014

    Report

    Report Number
    3004105610-2014-00042
    Event Type
    Injury
    Date Received
    November 7, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOM JTS EXTENDIBLE PROSTHESIS WAS IMPLANTED THREE YEARS AGO, WHEN THE PT WAS (B)(6) YEARS OLD. THE NEED TO REVISE THE JTS EXTENDIBLE PROSTHESIS IN A GROWING CHILD IS A WELL RECOGNIZED AND ANTICIPATED FAILURE MODE OF THIS DEVICE. THE DEVICE HAS NOW REACHED ITS MAXIMUM GROWTH LENGTH, AND THUS REQUIRES REPLACEMENT TO MEET THE NEEDS OF THE GROWING CHILD. THE COMPANY HAS DESIGNED A CUSTOM REVISION PROSTHESIS WHICH IS AWAITING THE SURGEON'S APPROVAL. THE CUSTOM IMPLANT IS SIMILAR TO METS MODULAR DISTAL FEMUR (K121029).

    Description of Event or Problem · 1

    WHEN THE PT WAS (B)(6) YEARS OLD, SHE UNDERWENT A SURGICAL PROCEDURE AS PART OF THE TREATMENT FOR OSTEOSARCOMA AND RECEIVED A CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT IN (B)(6) 2011. THE PT'S CUSTOM JTS DISTAL FEMUR IMPLANT IS REPORTED TO HAVE REACHED ITS MAXIMUM EXTENSION, AND THE PT'S SURGEON HAS REQUESTED DESIGN OF A NEW CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT FOR THIS PT. THE REVISION PROCEDURE DATE HAS BEEN SCHEDULED FOR MID (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720755 CUSTOM JTS DISTAL FEMUR REPLACEMENT IMPLANT DISTAL FEMUR IMPLANT JDI STANMORE IMPLANTS WORLDWIDE LTD. BME16554 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other