BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR IMPLANT

    MDR report key: 4373069 · Received December 24, 2014

    Report

    Report Number
    3004105610-2014-00174
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY CONFIRMS NO NON-CONFORMANCES WERE IDENTIFIED. REVIEW OF THE ORDER DETAILS AND THE SHIPPING DETAILS CONFIRMS THAT THE BUMPER PAD WAS PRE-ASSEMBLED WITH THE IMPLANT AND THEREFORE WAS NOT MISSING. THIS WAS COMMUNICATED TO THE SURGEON AND THE DEVICE WAS IMPLANTED SUCCESSFULLY WITH NO FURTHER COMPLAINTS REPORTED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR REPLACEMENT IMPLANT (K121029).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT THE DELIVERY OF THE DISTAL FEMUR REPLACEMENT IMPLANT DID NOT CONTAIN THE BUMPER PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851091 CUSTOM DISTAL FEMUR IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD. BME18630

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other