BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER SYSTEM

    MDR report key: 15499874 · Received September 28, 2022

    Report

    Report Number
    1038671-2022-01182
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    August 24, 2022
    Report Date
    November 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086396
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: RS GLENOID PLATE POST AUG, 8 DEG, RIGHT, 320-15-04, 7230722. EQ REVERSE TORQUE DEFINING SCREW KIT, 320-20-00, A080404. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 320-10-00, A049521. EQUINOXE REVERSE 42MM HUMERAL LINER +0, 320-42-00, A009504. EQ REV LOCKING SCREW, 320-15-05, A085019. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM, 300-01-11, A014595. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: 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 SHOULDER DISLOCATION AND REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 78 YO MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2022, DISLOCATED POSTOPERATIVELY, AND WAS REVISED TO EXACTECH DEVICES ON (B)(6) 2022. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    DEVICES WILL NOT BE RETURNED AS THE HOSPITAL KEEPS THEM. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825032 EQUINOXE PRIMARY SHOULDER SYSTEM PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE UNK 10885862086396

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention| H SEE H10