BEUDAMED
    FDA Adverse Event Other Summary report: N

    EQUINOXE

    MDR report key: 1963394 · Received January 11, 2011

    Report

    Report Number
    1038671-2011-00001
    Event Type
    Other
    Date Received
    January 11, 2011
    Date of Event
    July 26, 2010
    Report Date
    January 11, 2011
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE RETURNED DEVICES NOTED OBSERVATIONS CONSISTENT WITH IMPLANTATION AND REMOVAL OF THE DEVICE. A FUNCTIONAL TEST WAS ALSO CONDUCTED TO ASSESS THE TAPER CONNECTION BETWEEN THE REPLICATOR PLATE AND THE HUMERAL HEAD. A MINOR IMPACT LOAD WAS ABLE TO SUCCESSFULLY ENGAGE THE HUMERAL HEAD TAPER TO THE REPLICATOR PLATE TAPER. EFFORTS TO REMOVE THE TAPER FOLLOWING IMPACTION WERE UNSUCCESSFUL. THE RESULTS OF THE EVALUATION ARE INCONCLUSIVE TO THE CAUSE OF THE DISASSOCIATION; HOWEVER, THE RESULTS OF THE FUNCTIONAL TEST DEMONSTRATE THAT EACH IMPLANT CAN BE SUCCESSFULLY ENGAGED WITHOUT ISSUE, EVEN IN ITS USED STATE.

    Description of Event or Problem · 1

    REVISION OF SHOULDER COMPONENTS 3 YEARS POSTOPERATIVELY DUE TO HUMERAL HEAD TAPER NOT BEING FULLY ENGAGED TO THE REPLICATOR PLATE TAPER. THIS EVENT OCCURRED OUTSIDE OF THE UNITED STATES IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUINOXE PRIMARY HUMERAL STEM KWY EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention