BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4373554 · Received December 19, 2014

    Report

    Report Number
    3004105610-2014-00097
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    STANMORE IMPLANTS WORLWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121056
    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. AS THE DEVICE HAS BEEN IMPLANTED FOR OVER 10 YEARS IT IS LIKELY THAT THE WEAR OF THE BUSHES IS RELATED TO NORMAL WEAR AND TEAR OF THE DEVICE, HOWEVER, THIS CANNOT BE CONFIRMED WITH THE CURRENT AVAILABLE INFORMATION. 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 METS MODULAR DISTAL FEMUR (K121029).

    Additional Manufacturer Narrative · 1

    A REBUSHING PROCEDURE WAS SUCCESSFULLY PERFORMED WITH NO REPORTED COMPLICATIONS. REBUSHING IS AN ANTICIPATED EVENT DUE TO THE NATURE AND DESIGN OF THE IMPLANT, WHICH HAD BEEN IMPLANTED APPROXIMATELY NINE YEARS EARLIER. IT CONSISTS OF THE REPLACEMENT OF POLY COMPONENTS WHICH ARE SUSCEPTIBLE TO WEAR SUCH AS BEARINGS AND BUSHINGS, IN ADDITION TO THE AXLE AND RELATED RETAINING MECHANISMS. THIS COMPLAINT IS BEING CLOSED AND IS BEING TRACKED AND TRENDED. DEVICE WAS NOT RETURNED .

    Description of Event or Problem · 1

    THE SURGEON HAS REPORTED THAT A REVISION PROCEDURE IS REQUIRED TO RE-BUSH A CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT THAT WAS ORIGINALLY IMPLANTED IN (B)(6) 2004.

    Description of Event or Problem · 1

    THE SURGEON HAS REPORTED THAT A REVISION PROCEDURE IS REQUIRED TO RE-BUSH A CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT THAT WAS ORIGINALLY IMPLANTED IN (B)(6) 2004. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838134 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT PROSTHESIS, KNEE, FEMOROTIBIAL, CONS KRO STANMORE IMPLANTS WORLWIDE LTD BME10824

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other