BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL FEMUR JTS

    MDR report key: 4612239 · Received March 13, 2015

    Report

    Report Number
    3004105610-2015-00029
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    February 19, 2015
    Report Date
    February 19, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING HISTORY OF THE COMPONENT HAS BEEN REVIEWED AND CONFIRMED THAT NO ABNORMALITIES OR DEVIATIONS WERE REPORTED. THE COMPONENT THAT WAS IMPLANTED WAS DESIGNED TO BE EXTENDED OVER TIME. THIS HAS NOW REACHED THE END OF ITS LIFE AND THE PATIENT REQUIRES A LONGER PROSTHESIS. THERE IS NO ALLEGED FAILURE OF THE DEVICE TO MEET ITS PERFORMANCE EXPECTATIONS. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR PROXIMAL FEMUR IMPLANT (K121056).

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD A STANMORE NON-INVASIVE EXTENDIBLE PROXIMAL FEMUR REPLACEMENT WHICH WAS IMPLANTED IN (B)(6) 2011 FOLLOWING HER DIAGNOSIS WITH OSTEOSARCOMA. 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. THE IMPLANT WAS SUCCESSFULLY REVISED TO A NEW STANMORE NON-INVASIVE EXTENDIBLE PROXIMAL FEMUR REPLACEMENT IN (B)(6) 2015. 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. CORRECTED DATA: CUSTOM PROXIMAL FEMUR REPLACEMENT IMPLANT CORRECT TO PROXIMAL FEMUR JTS, CUSTOM PROXIMAL FEMORAL IMPLANT CORRECTED TO LIMB SALVAGE SYSTEM, OPERATOR OF DEVICE CORRECTED FROM HEALTH PROFESSIONAL TO PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PROXIMAL FEMUR JTS NON-INVASIVE GROWER PROCEDURE ON (B)(6) 2011. THE NON-INVASIVE GROWER HAS NOT REACHED MAXIMUM EXTENSION AND A REVISION PROCEDURE IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PROXIMAL FEMUR JTS NON-INVASIVE GROWER PROCEDURE ON (B)(6) 2011. THE NON-INVASIVE GROWER HAS NOW REACHED MAXIMUM EXTENSION AND A REVISION PROCEDURE IS REQUIRED. THIS IS A SUPPLEMENTAL REPORT TO 3004150610-2015-00029 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174483 PROXIMAL FEMUR JTS LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD BME 16425 BME 16425

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention