BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALL POLY TIBIAL COMPONENT

    MDR report key: 1620682 · Received March 1, 2010

    Report

    Report Number
    1038671-2010-00015
    Event Type
    Other
    Date Received
    March 1, 2010
    Date of Event
    January 12, 2010
    Report Date
    March 1, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE RETURNED DEVICE SHOWED THE DISTAL SURFACE OF THE TIBIAL COMPONENT PRESENTED WITH CEMENT WELL DISTRIBUTED ABOUT THE SURFACE, WITH EXCEPTION TO THE AREA TO THE LEFT OF THE KEEL, POSTERIOR TO THE KEEL AND ALONG THE ANTERIOR RIM. IT IS UNK IF THESE BARE AREAS WERE AS SHOWN OR COVERED WITH CEMENT AT THE TIME OF IMPLANTATION. THE SURFACE OF THE CEMENT REFLECTS THAT IT INTEGRATED WITH THE ADJACENT BONY SURFACE OF THE TIBIA. THE PROXIMAL SURFACE OF THE TIBIAL COMPONENT SHOWED MILD BURNISHING OF THE DISHED SURFACES. THIS IS CONSISTENT WITH CYCLIC LOADING FROM THE FEMORAL COMPONENT IN-VIVO.

    Description of Event or Problem · 1

    A TOTAL KNEE REPLACEMENT WAS REVISED APPROX 18 MONTHS POST OPERATIVELY DUE TO INFECTION. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL POLY TIBIAL COMPONENT TIBIAL INSERT HSH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention