BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIBIAL INSERT

    MDR report key: 1719453 · Received June 8, 2010

    Report

    Report Number
    1038671-2010-00078
    Event Type
    Other
    Date Received
    June 8, 2010
    Date of Event
    May 3, 2010
    Report Date
    June 8, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE RETURNED TIBIAL INSERT IDENTIFIED PITTING ON THE POSTERIOR OF THE BOTTOM SURFACE AND INDENTATIONS FROM THE SCREW HOLE COVERS. THE MUSHROOM WAS DEFORMED CONSISTENT WITH INSERTION INTO THE TIBIAL TRAY. THERE WAS PITTING ON THE POSTERIOR SPINE AND THE PROXIMAL SPINE CONTAINED DEFORMATIONS CONSISTENT WITH BONY IMPINGEMENT. BOTH CONDYLES HAD PITTING SPANNING THE ENTIRE MEDIA-LATERAL WIDTH AND ALMOST ALL OF THE ANTERIOR-POSTERIOR LENGTH.

    Description of Event or Problem · 1

    AFTER TOTAL KNEE ARTHROPLASTY, WOUND REMAINED RED, SWOLLEN AND UNCOMFORTABLE. COMPONENTS WERE REMOVED AND SPACER WAS PLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention