BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12376640 · Received August 27, 2021

    Report

    Report Number
    1038671-2021-00419
    Event Type
    Injury
    Date Received
    August 27, 2021
    Date of Event
    August 4, 2021
    Report Date
    May 24, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) AS REPORTED, APPROXIMATELY 5 MONTHS POSTOP THE INITIAL IMPLANT, THIS 59 Y/O MALE PATIENT HAD AN INFECTED SHOULDER AND THE SURGEON OPTED TO REMOVE THE 3 IMPLANTS, WASH OUT AND REPLACE WITH NEW IMPLANTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL NOT RETURN DUE TO FACILITY POLICY. ADDITIONAL INFORMATION: SECOND STAGE OF REVISION RECEIVED ON 4/26/2022: AS REPORTED, APPROXIMATELY 1 YEAR POST OP THE INITIAL RIGHT TSA, THIS MALE PATIENT WAS REVISED DUE TO AN INFECTION. PATIENT HAD AN INFECTED SHOULDER AND THE SURGEON OPTED TO REMOVE ALL IMPLANTS, WASH OUT AND REPLACE WITH A CEMENT SPACER. THIS ADDITIONAL INFORMATION IS REGARDING THE SECOND STAGE OF THE REVISION WHERE THE PREVIOUSLY PLACED CEMENT SPACER WAS REMOVED AND THE NEW HUMERAL LINER AND GLENOSPHERE WERE PLACED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. (H3) ADDITIONAL INFORMATION RECEIVED REGARDING THE 2ND STAGE OF TREATMENT BEING COMPLETED. INVESTIGATION WAS CLOSED BEFORE THE NEW INFORMATION WAS RECEIVED THE NEW INFORMATION DOES NOT CHANGE THE INVESTIGATION RESULTS. THERE ARE NO CHANGES TO THE CURRENT INVESTIGATION NEEDED.

    Additional Manufacturer Narrative · 0

    SECTION H10: H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE(S): 321-20-00, 6801314 - EQUINOXE REVERSE SHOULDER DRILL KIT. 320-15-01, 6688580 - EQ REV GLENOID PLATE. 320-15-05, 6746541 - EQ REV LOCKING SCREW. 320-01-42, 6504821 - EQUINOXE REVERSE 42MM GLENOSPHERE. 300-01-13, 6746315 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM. 320-20-00, 6811022 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-10-00, 6763100 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 5 MONTHS POSTOP THE INITIAL IMPLANT, THIS (B)(6) MALE PATIENT HAD AN INFECTED SHOULDER AND THE SURGEON OPTED TO REMOVE THE 3 IMPLANTS, WASH OUT AND REPLACE WITH NEW IMPLANTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICES WILL NOT RETURN DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278344 EQUINOXE REVERSE 42MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-42-00 UNK 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R