BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR IMPLANT

    MDR report key: 4373406 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00140
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    July 1, 2013
    Report Date
    March 19, 2013
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. REVIEW OF THE PT'S HISTORY CONFIRMS THAT THE TIBIAL COMPONENT WAS REPLACED IN (B)(4) 2012. REVIEW OF THE RADIOGRAPHS IDENTITY THAT A COLLAR HAS BEEN ADDED TO THE IMPLANT. THIS IS INDICATIVE OF AN EARLIER COLLAPSE OF THE GROWING PROSTHESIS, HOWEVER, OUR RECORDS SHOW NO REPORT OF THIS AND THERE IS NO RECORD OF THE COLLAR BEING DESIGNED FOR THIS PT. AT THIS TIME, THE ROOT CAUSE IS UNK. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED EVENT. 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 PT UNDERWENT A PRIMARY PROCEDURE ON (B)(6) 2005 TO IMPLANT A MINIMALLY INVASIVE GROWING PROSTHESIS. SUBSEQUENTLY THE PT WAS REVISED ON (B)(6) 2013 DUE TO A FAILURE IN THE MECHANISM OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847172 CUSTOM DISTAL FEMUR IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME12008

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Required Intervention