BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT

    MDR report key: 4373323 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00123
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    November 1, 2012
    Report Date
    October 15, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    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 SURGEON CONFIRMED THAT THE USE OF THE UNCEMENTED TIBIAL COMPONENTS DURING THE PRIMARY PROCEDURE WAS TO ALLOW FOR FURTHER BONE GROWTH ONCE THE PROSTHESIS WAS IN PLACE. THIS GROWTH HAS NOT OCCURRED, WHICH HAS CAUSED THE STEM TO BE LOOSE IN THE BONE CANAL. REQUESTS ARE BEING MADE FOR ADDITIONAL 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).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL REVISION OF THE JTS GROWER. A DEFINITIVE ROOT CAUSE OF THE LOOSENING HAS NOT BEEN IDENTIFIED, HOWEVER LOOSENING CAN BE A WELL-KNOWN MODE OF FAILURE FOR ORTHOPAEDIC IMPLANTS, WHICH MAY OCCUR AS AN EARLY OR A LATE COMPLICATION. IT WAS NOTED THAT THE TIBIAL STEM HAS, BY DESIGN, A SLIDING FIT WITHIN THE MEDULLARY CANAL TO ALLOW GROWTH OF THE PROXIMAL TIBIAL BONE. THERE WERE NO REPORTED COMPLICATIONS RESULTING FROM THE REVISION SURGERY. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED. A REQUEST FOR FURTHER INFORMATION WAS MADE IN RELATION TO THIS INCIDENT, HOWEVER IT WAS CONCLUDED THAT THE REQUESTED INFORMATION IS NOT AVAILABLE TO STANMORE. CORRECTED DATA: ADVERSE EVENT AND/OR PRODUCT PROBLEM: ADVERSE EVENT ONLY. TYPE OF REPORTABLE EVENT: CORRECTED TO SERIOUS INJURY. DEVICE MANUFACTURE DATE CORRECTED TO 03/15/2005.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT UNDERWENT A PRIMARY PROCEDURE TO IMPLANT A NON-INVASIVE EXTENDIBLE DISTAL FEMUR IMPLANT ON (B)(6) 2005 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE PROSTHESIS BEING LOOSE IN THE BONE CANAL FOLLOWING THE GROWTH OF THE BONE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE TO IMPLANT A NONINVASIVE EXTENDIBLE DISTAL FEMUR IMPLANT ON (B)(6) 2005 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO THE PROSTHESIS BEING LOOSE IN THE BONE CANAL FOLLOWING THE GROWTH OF THE BONE. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00123 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847308 CUSTOM JTS NON-INVASIVE DISTAL FEMUR IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME11357

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention