BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM DISTAL FEMUR JTS

    MDR report key: 6127400 · Received November 25, 2016

    Report

    Report Number
    3004105610-2016-00122
    Event Type
    Injury
    Date Received
    November 25, 2016
    Date of Event
    March 21, 2012
    Report Date
    March 21, 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 IN-SITU IMPLANT REACHED MAXIMUM EXTENSION AFTER 3 YEARS IN PLACE. A NEW CUSTOM DISTAL FEMUR NON-INVASIVE HAS BEEN SUCCESSFULLY IMPLANTED WITH NO REPORTS OF COMPLICATIONS. THE PATIENT HAS REACHED THE MAXIMUM LENGTH ASSOCIATED WITH THE IN-SITU DEVICE, DUE TO SKELETAL IMMATURITY AND CONTINUED GROWTH. THERE IS NO FAILURE OF THE IN-SITU IMPLANT; IT FUNCTIONED AS INTENDED. THE COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED. THIS COMPLAINT FILE WAS REVIEWED AS PART OF SIW COMPLAINT FILE REMEDIATION PROGRAMME AND IT HAS BEEN DETERMINED THAT AN MDR SHOULD BE FILED. THIS COMPLAINT WAS RECEIVED BY SIW IN MARCH, 2012.

    Description of Event or Problem · 1

    (B)(4). IT HAS BEEN REPORTED THAT THE PATIENT'S DISTAL FEMUR JTS IMPLANT HAS REACHED MAXIMUM EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777932 CUSTOM DISTAL FEMUR JTS LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN 14477 PIN 14477

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention