BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)

    MDR report key: 8841337 · Received July 30, 2019

    Report

    Report Number
    1038671-2019-00380
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    July 1, 2019
    Report Date
    October 8, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862083876
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) EXPIRATION DATE: 12-APR-2027; (G5) PMA/510(K)NUMBER: K042021; (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PAIN. (H5) DEVICE MANUFACTURE DATE: 12-APR-2017. ACCORDING THE INFORMATION PROVIDED, ¿UPON REVIEW OF X-RAY IT WAS DETERMINED THE HUMERAL HEAD (SIZE 44 SHORT) WAS OVERSTUFFING THE JOINT. SURGEON CHOSE TO REVISE BY DOWNSIZING THE HEAD TO A 38MM SHORT.¿ A REVIEW OF THE DHR AND/OR THE STERILIZATION RECORDS WAS NOT CONDUCTED BECAUSE THE EVENT AS DESCRIBED DOES NOT APPEAR TO BE RELATED TO THE DESIGN, MANUFACTURING, OR REASONABLY FORESEEABLE MISUSE OF THE DEVICE. INTRACTABLE PAIN IS LISTED IN THE TOTAL JOINT SURGERY RISKS SECTION OF THE EQUINOXE SHOULDER SYSTEM IFU 700-096-060 REV M.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: 300-10-45, (B)(4), ANATOMIC REPLICATOR PLATE 4.5MM, 300-20-02, (B)(4), TORQUE DEFINING SCREW KIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 18 MONTHS AGO, THIS FEMALE PATIENT RECEIVED A RIGHT TOTAL SHOULDER PROSTHESIS. THE PATIENT PRESENTED AT THE PHYSICIAN¿S OFFICE WITH A PAINFUL TOTAL SHOULDER AND NO SIGN OF INFECTION. UPON REVIEW OF X-RAY, IT WAS DETERMINED THE HUMERAL HEAD (SIZE 44 SHORT) WAS OVERSTUFFING THE JOINT. LAB WORK CONFIRMED THERE WAS NO SIGNS OF INFECTION. THE SURGEON¿S PLAN WAS TO REVISE BY DOWNSIZING THE HEAD TO A 38MM SHORT. REPORTEDLY, THERE WERE NO COMPLICATIONS AND THE PATIENT WAS STABLE LEAVING OR. THE REMOVED DEVICES ARE NOT BEING RETURNED TO THE MANUFACTURER PER HOSPITAL PROTOCOL. NO FURTHER INFORMATION AVAILABLE IS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636181 EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA) HUMERAL HEAD SHORT, 44MM (ALPHA) KWT EXACTECH, INC. 10885862083876

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention