BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT

    MDR report key: 4688972 · Received April 7, 2015

    Report

    Report Number
    3004105610-2015-00036
    Event Type
    Malfunction
    Date Received
    April 7, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 16, 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

    THE DEVICE WAS NOT ABLE TO BE RETURNED, THEREFORE HAS NOT BEEN EVALUATED. THE MANUFACTURING HISTORY HAS BEEN REVIEWED AND NO ABNORMALITIES OR DEVIATIONS WERE IDENTIFIED. INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR DISTAL FEMUR (K121029).

    Additional Manufacturer Narrative · 1

    THE RE-BUSHING WAS PERFORMED ON A DISTAL FEMUR IMPLANT AFTER 5 AND A HALF YEARS IMPLANTED. THE RE-BUSH INCLUDED THE TIBIAL COMPONENT, BEARING, BUSHES, AXLE AND CIRCLIP. THE ORIGINAL CIRCLIP WAS OBSERVED TO APPEAR INTACT AND DID NOT THUS FRACTURE. STANMORE CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE DISENGAGED CIRCLIP. TYPICALLY A DISENGAGED CIRCLIP IS THE RESULT OF AN INCOMPLETE OR INCORRECT INSERTION AT THE TIME OF IMPLANT. THE RE-BUSH PROCEDURE WAS SUCCESSFULLY PERFORMED WITH NO REPORTED COMPLICATIONS. THIS COMPLAINT IS BEING CLOSED AND WILL BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON THAT A REVISION SURGERY WAS REQUIRED DUE TO DISENGAGEMENT OF THE CIRCLIP. THE SURGEON WAS UNABLE TO RETRIEVE THE CIRCLIP AS IT WAS EMBEDDED IN SCAR TISSUE AND REMOVING IT WOULD HAVE DISRUPTED THE TISSUE.

    Description of Event or Problem · 1

    SUPPLEMENTAL REPORT TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228501 CUSTOM DISTAL FEMUR REPLACEMENT IMPLANT DISTAL FEMUR IMPLANT KRO STANMORE IMPLANTS WORLDWIDE LTD BME14926

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention