BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION(TM) MP TIBIAL BASE

    MDR report key: 4149442 · Received October 7, 2014

    Report

    Report Number
    3010536692-2014-01454
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    July 18, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. THE TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2014-01145.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY THE POLY WAS NOT ENGAGING TO POSTERIOR RIM OF THE TRAY. IT TOOK SURGEON EXTRA MALLET IMPACTION TO TRY AND SEAT THE POLY. THAT'S WHEN HE NOTICED THE TIBIAL COMPONENT WAS LOOSE FROM THE CEMENT MANTLE. HE REMOVED THE CEMENT CAREFULLY AND NO RECUTS WERE DONE BUT NOTICED A SMALL FRACTURE IN THE MEDIAL COMPARTMENT. HE AGAIN TRIED TO SEAT POLY TO THE TRAY ON THE BACK TABLE BUT IT WAS NOT SEATING AT ALL. I OPENED ANOTHER POLY. HE IMPACTED TO THE TRAY AND LOCKED IN . HE CEMENTED IT IN APPROPRIATELY. SURGERY TIME WAS EXTENDED MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626841 EVOLUTION(TM) MP TIBIAL BASE KNEE COMPONENT JWH MICROPORT ORTHOPEDICS INC. 1545877

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention