BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR JTS REPLACEMENT IMPLANT

    MDR report key: 4707082 · Received April 10, 2015

    Report

    Report Number
    3004105610-2015-00041
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    April 10, 2015
    Report Date
    April 10, 2015
    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

    AN EVENT REGARDING MAXIMUM EXTENSION INVOLVING A NON-INVASIVE GROWER (JTS) WAS REPORTED. THE DEVICE WAS IMPLANTED 3 YEARS AGO WHEN THE PATIENT WAS 8 YEARS OLD AND STILL SKELETALLY IMMATURE. X-RAY REVIEW WAS NOT PERFORMED AS X-RAYS WERE NOT PROVIDED FOR REVIEW. REQUESTS FOR FURTHER INFORMATION ON 9TH DEC 2016 DETERMINED THAT NO FURTHER INFORMATION WAS AVAILABLE FOR THIS COMPLAINT. THERE IS NO INDICATION OF DEVICE OR MANUFACTURING RELATED ISSUES HAVE BEEN IDENTIFIED. A REVISION RELATED TO A MINIMALLY INVASIVE/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. SIW WILL CONTINUE TO MONITOR FOR TRENDS. THIS COMPLAINT FILE WAS REVIEWED AS PART OF SIW COMPLAINT FILE REMEDIATION PROGRAMME AND IT HAS BEEN DETERMINED THAT AN MDR SHOULD BE FILED. PROSTHESIS, KNEE, FEMOROTIBIAL, CONS CORRECTED TO LIMB SALVAGE SYSTEM. K121056 CORRECTED TO K133152.

    Additional Manufacturer Narrative · 1

    A REVIEW OF MANUFACTURING RECORDS CONFIRMS THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT NO NON-CONFORMITIES WERE IDENTIFIED. THE INVESTIGATION IS ONGOING, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    PATIENT REQUIRES A REVISION PROCEDURE AS THE JTS HAS REACHED IT'S MAXIMUM EXTENSION. NO ALLEGED MALFUNCTION. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00041 ((B)(4)).

    Description of Event or Problem · 1

    PATIENT REQUIRES A REVISION PROCEDURE AS THE JTS HAS REACHED IT'S MAXIMUM EXTENSION. NO ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240283 CUSTOM DISTAL FEMUR JTS REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME17371 BME 17371

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention