BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8859907 · Received August 5, 2019

    Report

    Report Number
    1038671-2019-00390
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    July 17, 2019
    Report Date
    November 5, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079312
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER: (B)(6); EXPIRATION DATE: 11-AUG-2027, INITIAL REPORTER OCCUPATION: PHYSICIAN, PMA/510(K)NUMBER: K042021, PRIMARY SURGERY: (B)(6) 2018. LOOSENING NOTED ON X-RAY AROUND HUMERAL COMPONENT. PATIENT WAS WATERSKIING IN AUGUST AFTER SURGERY WHICH WAS NOTED AS PROBABLE CAUSE OF LOOSENING. UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED PROBLEM AND NO ALLEGATION AGAINST THE DEVICE. IMPLANTATION OF A TOTAL JOINT COULD RESULT PAIN, INFECTION, OR LOOSENING OF TOTAL JOINT HARDWARE. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS THE PATIENT¿S CONDITION AND ACTIVITIES. DEVICE MANUFACTURE DATE: 11-AUG-2017. CORRECTIONS MADE IN THE FOLLOWING SECTION(S): PLEASE DISREGARD LOT NUMBER PROVIDED, IT WAS ACTUALLY THE SERIAL NUMBER. LABELED FOR SINGLE USE SHOULD BE YES.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: 300-20-02, 5415004, TORQUE SCREW KIT; 300-10-45, 5325753, 4.5MM REPLICATOR PLATE; 310-01-50, 5314334, HUMERAL HEAD SHORT 50MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ¿LARGE BUILT¿ 70 YO MALE PATIENT¿S SHOULDER WAS REVISED DUE TO LOOSENED COMPONENTS NOTED ON X-RAYS. REPORTEDLY, THE PATIENT WAS WATERSKIING APPROXIMATELY 3 MONTHS AFTER THE INITIAL SURGERY, WHICH WAS NOTED AS PROBABLE CAUSE OF LOOSENING. THE HUMERAL HEAD IMPLANT REMOVED EASILY WITH COBB ELEVATOR. REMAINDER OF HUMERAL CONSTRUCT REMOVED BY HAND. CULTURES WERE TAKEN. GLENOID COMPONENT INSPECTED AND NO LOOSENING OR WEAR NOTED. HUMERAL CANAL WAS RE-REAMED AND BROACHED TO A SIZE 12MM. IT WAS THEN ASSEMBLED WITH A 1.5 REPLICATOR PLATE AND IMPLANTED WITH ANTIBIOTIC CEMENT. A SIZE 50MM X 19MM SHORT HEAD WAS AFFIXED AND THE WOUND WAS CLOSED. NO INSTABILITY NOTED AT CLOSURE OF THE WOUND. THE PATIENT LEFT THE OR IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652727 EQUINOXE HUMERAL STEM PRIMARY, PRESS FIT 11MM KWT EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM UNK 10885862079312

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention