BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

    MDR report key: 4373014 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00193
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    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 PATIENT UNDERWENT SUCCESSFUL REVISION SURGERY RESULTING IN THE IMPLANTATION OF A NEW DISTAL FEMUR. THE FRACTURED DISTAL FEMUR JTS WAS IN-SITU FOR 4 YEARS. THERE ARE NO ADDITIONAL DETAILS AVAILABLE WHICH DEFINITIVELY ASSIGN A ROOT CAUSE TO THE FRACTURE, HOWEVER IMPLANT FRACTURES ARE WELL RECOGNIZED, LATE POST-OPERATIVE OCCURRENCES MAY BE ASSOCIATED WITH EXCESSIVE LOADS, IMPACT OR TRAUMA IN IMPLANTED PATIENTS. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    THE IMPLANT HAS NOT BEEN RETURNED FOR EVAL, THEREFORE, A VISUAL INSPECTION HAS NOT BEEN POSSIBLE. A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THE REPORTED FRACTURE. 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 THE METS MODULAR DISTAL FEMUR (K121029).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT IS BEING REVISED DUE TO A BROKEN STEM. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00193 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT IS BEING REVISED DUE TO A BROKEN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850786 JTS EXTENDIBLE DISTAL FEMORAL IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME15370

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention