BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT

    MDR report key: 4373033 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00189
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    January 28, 2003
    Report Date
    January 30, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. A CORRECTIVE AND PREVENTATIVE ACTION WAS RAISED TO INVESTIGATE THE ISSUES WITH THE LOCKING SCREWS. REQUESTS ARE BEING MADE FOR ADDITIONAL INFORMATION AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFORMATION IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE SURGEON CAME ON-SITE AND GAVE A PRESENTATION RELATING TO NUMEROUS ISSUES HE HAD EXPERIENCED. THE MAJORITY OF WHICH HAD BEEN INVESTIGATED IN SEPARATE COMPLAINTS. THIS COMPLAINT RELATES TO THE JTS NON-INVASIVE GROWER LOCKING GRUB SCREW NOT LOCKING/FRACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850899 CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME9778

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention