BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 16956147 · Received May 18, 2023

    Report

    Report Number
    1038671-2023-01032
    Event Type
    Injury
    Date Received
    May 18, 2023
    Date of Event
    March 31, 2023
    Report Date
    May 11, 2026
    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

    D10: CONCOMITANTS: 6697488, 300-01-17 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM. 6917481, 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE. 6800489, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 6805813, 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG. 7096562, 320-15-05 - EQ REV LOCKING SCREW. 7116588, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S297616, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S295217, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S296088, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. S294848, 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    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, FINISHED PRODUCT RELEASE FOR THE LINER WAS REVIEWED. THE CAUSE OF SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED-NO CLINICAL INFORMATION WAS PROVIDED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 75 YO MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 1 YEAR 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO INFECTION. THE LINER, GLENOSPHERE, AND ADAPTER TRAY WERE REVISED TO NEW COMPONENTS. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE IMAGES OR PATIENT IMAGING WERE AVAILABLE. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE PRODUCT IS NOT RETURNING. THE CUSTOMER DISPOSED OF THE DEVICES. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608965 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +0 UNK 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1