BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL TIBIA JTS

    MDR report key: 4373037 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00207
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. THE SURGEON ADVISED THAT HE BELIEVED THE FAILURE TO LENGTHEN WAS DUE TO TISSUE TENSION IN THE PT'S LEG AND NOT DUE TO THE DRIVE UNIT NOT WORKING. REQUESTS ARE BEING MADE FOR ADD'L INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. 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 A SURGEON THAT THE JTS DRIVE UNIT WAS NOT FUNCTIONING AS EXPECTED. IT WORKED FOR A FEW MINS, THEN STOPPED. IT WAS TRIED AGAIN AFTER A PERIOD OF TIME AND THEN ONLY WORKED FOR APPROXIMATELY 40 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851423 CUSTOM PROXIMAL TIBIA JTS LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME15279

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female