BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    MDR report key: 24675125 · Received March 24, 2026

    Report

    Report Number
    1038671-2026-00331
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 24, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 300-21-00 - 0MM FIXED ANGLED KIT 5329105. 300-30-06 - EQUINOXE PRESERVE STEM 6MM 5297434. 310-01-47 - EQUINOXE, HUMERAL HEAD SHORT, 47MM (BETA) 4063398. 315-35-00 - GLND KWIRE 4969803. 314-13-02 - EQUINOXE CAGE GLENOID SMALL, ALPHA 5310215. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A LEFT TOTAL SHOULDER ARTHROPLASTY. THE PATIENT LATER REQUIRED A REVISION FOR UNSPECIFIED REASONS. DURING THE REVISION PROCEDURE, THE SURGEON CONVERTED THE ANATOMIC TOTAL SHOULDER ARTHROPLASTY TO A REVERSE TOTAL SHOULDER ARTHROPLASTY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733341 EQUINOXE PRIMARY SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization SEE H11