BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

    MDR report key: 4360982 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00084
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    July 2, 2012
    Report Date
    April 23, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IMPLANTED 4 YEARS PRIOR TO RECEIPT OF THE COMPLAINT WHEN THE PATIENT WAS (B)(6) AND STILL SKELETALLY IMMATURE. X-RAY REVIEW CONFIRMED THAT THE DEVICE HAS REACHED ITS MAXIMUM EXTENSION AND NO INDICATION OF DEVICE OR MANUFACTURING RELATED ISSUES HAS BEEN IDENTIFIED. A REVISION RELATED TO A NON-INVASIVE GROWING DEVICE REACHING MAXIMUM EXTENSION IS EXPECTED IN PATIENTS WHO ARE CONTINUING TO GROW. THERE IS NO DEVICE FAILURE; THE DEVICE FUNCTIONED AS INTENDED AND IS BEING REPLACED, AS ANTICIPATED, SO AS TO ALLOW FOR THE PATIENT'S CONTINUED GROWTH. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. STANMORE WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTED DATA - ADVERSE EVENT AND/OR PRODUCT PROBLEM - CORRECTED TO ADVERSE EVENT BRAND NAME - CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT CORRECTED TO JTS EXTENDIBLE DISTAL FEMORAL IMPLANT. COMMON DEVICE NAME - DISTAL FEMUR IMPLANT CORRECTED TO LIMB SALVAGE SYSTEM

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE WAS USED AS INTENDED AND HAS REACHED ITS MAXIMUM EXTENSION, THEREFORE, A REVISION PROCEDURE WAS REQUIRED TO A IMPLANT A LONGER PROSTHESIS. THERE WAS NO REPORTED FAILURE OF THE DEVICE. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE TO IMPLANT A NONINVASIVE EXTENDIBLE DISTAL FEMUR IMPLANT ON (B)(6) 2008 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE PROSTHESIS REACHING FULL EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE TO IMPLANT A NONINVASIVE EXTENDIBLE DISTAL FEMUR IMPLANT ON (B)(6) 2008 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE PROSTHESIS REACHING FULL EXTENSION. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00084 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837809 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME13576

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention