BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMORAL IMPLANT

    MDR report key: 4373039 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00203
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    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 IMPLANT HAS NOT BEEN RETURNED FOR EVAL, THEREFORE, A VISUAL INSPECTION HAS NOT BEEN POSSIBLE. A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. IT IS LIKELY THAT THE FAILURE OF THE COMPONENT IS LINKED TO THE IMPLANTATION TIME OF 11.5 YEARS. IT WAS ALSO REPORTED BY THE SURGEON THAT THE PT WAS OVERWEIGHT. THIS MAY ALSO HAE BEEN A CONTRIBUTING FACTOR. 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 A SURGEON THAT A PT REQUIRED A REVISION PROCEDURE DUE TO THE FRACTURE OF THE TIBIAL COMPONENT AT THE PROXIMAL END OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850901 CUSTOM DISTAL FEMORAL IMPLANT DISTAL FEMORAL IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME9490

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention