BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4512106 · Received February 6, 2015

    Report

    Report Number
    3004105610-2015-00006
    Event Type
    Malfunction
    Date Received
    February 6, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 8, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO NON-CONFORMANCES WERE IDENTIFIED. THE INVESTIGATION IS ONGOING, A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THE CUSTOMER DISTAL FEMUR REPLACEMENT IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR IMPLANT K121029.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE SURGEON STATING THAT A PATIENT FRACTURED THE TIBIAL COMPONENT OF THEIR CUSTOMER DISTAL FEMUR REPLACEMENT IMPLANT WHILST PLAYING FOOTBALL DURING THE (B)(6) OF 2014. SURGEON REPORTS THAT AN ASEPTIC LOOSENING HAS NOW OCCURRED AND A REVISION PROCEDURE IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87548 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT PROSTHESIS, KNEE, FEMOROTIBIAL, CONS KRO STANMORE IMPLANTS WORLDWIDE LTD. BME17609 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other