BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR IMPLANT

    MDR report key: 4373359 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00121
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    November 20, 2012
    Report Date
    October 25, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    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 SMILES FIXED HINGE. THE FRACTURED CUSTOM MIG DISTAL FEMUR WAS IN-SITU FOR 7 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 OFTEN 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

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. REVIEW OF THE SUPPLIED X-RAYS SUGGESTS THAT THE STEM WAS ORIGINALLY DESIGNED FOR THE PT AS A (B)(6) YEAR OLD IS NO LONGER SUITABLE FOLLOWING HER GROWTH. IT IS POSSIBLE, THAT DUE TO THE PT'S GROWTH THAT THE STEM HAS UNDERGONE OVERLOADING, WHICH MAY HAVE RESULTED IN THE REPORTED FRACTURE. IT IS NOT POSSIBLE TO CONFIRM THIS WITH THE CURRENT AVAILABLE INFO. REQUESTS ARE BEING MADE FOR ADDITIONAL INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. PLEASE NOTE THAT THIS CUSTOMER IMPLANT IS SIMILAR TO METS MODULAR DISTAL FEMORAL IMPLANT (K120992).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PT UNDERWENT A PRIMARY PROCEDURE TO IMPLANT A MINIMALLY INVASIVE GROWING PROSTHESIS ON (B)(6) 2005 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO A FRACTURE OF THE PROSTHESIS NEAR THE PROXIMAL END.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE PATIENT UNDERWENT A PRIMARY PROCEDURE TO IMPLANT A MINIMALLY INVASIVE GROWING PROSTHESIS ON (B)(6) 2005 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2012 DUE TO A FRACTURE OF THE PROSTHESIS NEAR THE PROXIMAL END. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00121 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847315 CUSTOM DISTAL FEMUR IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME12008

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention