BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS DRIVE UNIT SET

    MDR report key: 16486444 · Received March 6, 2023

    Report

    Report Number
    3004105610-2023-00031
    Event Type
    Malfunction
    Date Received
    March 6, 2023
    Date of Event
    February 7, 2023
    Report Date
    March 6, 2023
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS EVENT IS RELATED TO A JTS DRIVE UNIT WHICH IS USED IN CONJUNCTION WITH THE JTS NON-INVASIVE EXTENDIBLE IMPLANT (K092138) SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT AVAILABLE.

    Description of Event or Problem · 0

    A FAILED LENGTHENING OF A RIGHT PROXIMAL FEMUR JTS WAS REPORTED. AS REPORTED: "THIS BOY¿S GROWER IS STUCK. PLEASE CAN WE ARRANGE AN APPOINTMENT FOR US ALL TO SEE HIM TOGETHER TO HAVE ONE LAST GO AT LENGTHENING HIM. IF WE CAN¿T GET IT MOVING HE¿LL NEED A REVISION OF THE WHOLE IMPLANT INCLUDING THE OSSEO-INTEGRATED STEM. HE HAS BEEN SUCCESSFULLY LENGTHENED BY 6MM TO DATE BUT UNABLE TO LENGTHEN FURTHER. LAST SUCCESSFUL LENGTHENING WAS IN NOVEMBER. WE AIMED TO LENGTHEN BY 3MM BUT ONLY MANAGED 2 AS MOTOR WAS VERY STICKY AND IT HAS NOT GONE FURTHER SINCE THIS TIME. THERE WERE NO ISSUES WITH PREVIOUS 2 LENGTHENING¿S OF 2MM IN (B)(6) 2022."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531530 JTS DRIVE UNIT SET PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male Other