BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT

    MDR report key: 4364949 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00115
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    November 12, 2012
    Report Date
    October 15, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD A STANMORE NON-INVASIVE EXTENDIBLE DISTAL FEMUR REPLACEMENT WHICH WAS IMPLANTED IN (B)(6) 2009 FOLLOWING HER DIAGNOSIS WITH OSTEOSARCOMA OF THE LEFT FEMUR. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. IT SHOULD BE NOTED THAT THE NEED TO REVISE THE NON-INVASIVE EXTENDIBLE PROSTHESIS IN A GROWING CHILD IS A WELL-RECOGNISED AND ANTICIPATED FAILURE MODE OF THE DEVICE. THE DEVICE REACHED ITS MAXIMUM GROWTH LENGTH, AND THUS REQUIRED REPLACEMENT TO MEET THE NEEDS OF THE GROWING CHILD. THERE IS NO INDICATION OF 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. SIW WILL CONTINUE TO MONITOR FOR TRENDS.

    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 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 NON-INVASIVE EXTENDIBLE DISTAL FEMUR IMPLANT ON (B)(6) 2009 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE PROSTHESIS REACHING FULL EXTENSION. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00115 (B)(4).

    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) 2009 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE PROSTHESIS REACHING FULL EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838297 CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME14284

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention