BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT

    MDR report key: 4373360 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00120
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    November 1, 2009
    Report Date
    October 3, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE WAS USED AS INTENDED AND HAS REACHED ITS MAXIMUM EXTENSION, THEREFORE, A REVISION PROCEDURE WAS REQUIRED TO A LONGER PROSTHESIS. THERE WAS NO REPORTED FAILURE OF THE DEVICE. PLEASE NOTE THAT THIS CUSTOMER IMPLANT IS SIMILAR TO JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT UNDERWENT A PRIMARY PROCEDURE TO IMPLANT A NONINVASIVE EXTENDIBLE DISTAL FEMUR IMPLANT ON (B)(6) 2009 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE PROSTHESIS REACHING FULL EXTENSION. THE PT IS ALSO REPORTING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847157 CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME14478

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention