BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR JTS

    MDR report key: 6098389 · Received November 14, 2016

    Report

    Report Number
    3004105610-2016-00115
    Event Type
    Injury
    Date Received
    November 14, 2016
    Report Date
    October 28, 2016
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS REACHED ITS MAXIMUM EXTENSION AND NOW REQUIRES REVISION. WE ARE AWAITING THE OUTCOME OF THE REVISION SURGERY TO ENSURE THAT THERE ARE NO OTHER FACTORS INVOLVED IN THIS CASE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IMPLANTED IN (B)(6) 2015 WHEN THE PATIENT WAS (B)(6) AND STILL SKELETALLY IMMATURE. X-RAY REVIEW CONFIRMED THAT THE DEVICE HAS NEARLY REACHED ITS MAXIMUM EXTENSION AND NO INDICATION OF DEVICE OR MANUFACTURING RELATED ISSUES HAS BEEN IDENTIFIED. A REVISION PROCEDURE WAS COMPLETED WITH NO REPORTED COMPLICATIONS. A REVISION RELATED TO A NON-INVASIVE GROWING DEVICE REACHING MAXIMUM EXTENSION IS EXPECTED IN PATIENTS WHO ARE CONTINUING TO GROW. 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. STANMORE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENTS DISTAL FEMUR JTS HAS REACHED MAXIMUM EXTENSION. THE PATIENT REQUIRES A NEW IMPLANT. REF: (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PATIENTS DISTAL FEMUR JTS HAS REACHED MAXIMUM EXTENSION. THE PATIENT REQUIRES A NEW IMPLANT. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2016-00115 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750399 DISTAL FEMUR JTS LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 19159 PIN 19159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention