BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4898187 · Received July 1, 2015

    Report

    Report Number
    3004105610-2015-00061
    Event Type
    Injury
    Date Received
    July 1, 2015
    Report Date
    June 4, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K140898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRM THAT THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE RADIOGRAPHS THAT WERE PROVIDED CONFIRM THE REPORTED ASEPTIC LOOSENING. A "CEMENT OVER PROXIMAL FEMUR DEVICE" WILL BE IMPLANTED TO SECURE THE DISTAL FEMUR IN SITU, AS THAT DEVICE WILL NOT BE EXPLANTED. THE DEVICE WAS IMPLANTED IN 1993, THEREFORE HAS BEEN IN SITU FOR 22 YEARS; WELL BEYOND THE 10 YEAR EXPECTED LIFE OF THE DEVICE. THE ASEPTIC LOOSENING OF THIS DEVICE IS LIKELY ATTRIBUTED TO THE NORMAL WEAR PROCESSES OF A REPLACEMENT IMPLANT THAT HAS BEEN IN SITU FOR 22 YEARS. THE REASON FOR THE FAILURE OF THIS DEVICE IS MOST LIKELY RELATED TO THE NORMAL WEAR PROCESSES OF A REPLACEMENT IMPLANT. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121029).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL REVISION SURGERY RESULTING IN THE IMPLANTATION OF A CUSTOM CEMENT OVER PROXIMAL FEMUR DEVICE. THE ASEPTIC LOOSENING OF THE ORIGINAL IMPLANT MAY BE ATTRIBUTED TO THE NORMAL WEAR PROCESS OF A REPLACEMENT IMPLANT THAT HAS BEEN IN-SITU FOR 22 YEARS. REVISION SURGERY WAS COMPLETED WITH NO REPORTED COMPLICATIONS. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED

    Description of Event or Problem · 1

    THE SURGEON HAS REQUESTED A NEW "PATIENT SPECIFIC CEMENT OVER PROXIMAL FEMUR" TO SECURE THE PATIENT'S CURRENTLY IMPLANTED DISTAL FEMUR DEVICE WHICH HAS LOOSENED ASEPTICALLY. THE REVISION PROCEDURE IS SCHEDULED TO TAKE PLACE ON (B)(6) 2015.

    Description of Event or Problem · 1

    THE SURGEON HAS REQUESTED A NEW "PATIENT SPECIFIC CEMENT OVER PROXIMAL FEMUR" TO SECURE THE PATIENT'S CURRENTLY IMPLANTED DISTAL FEMUR DEVICE WHICH HAS LOOSENED ASEPTICALLY. THE REVISION PROCEDURE IS SCHEDULED TO TAKE PLACE ON (B)(6) 2015. THIS IA A SUPPLEMENTAL REPORT TO 3004105610-2015-00061 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429651 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD BME 2482 BME 2482

    Patients

    Seq Age Sex Outcome Treatment
    1 Other