BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    MDR report key: 23489371 · Received November 6, 2025

    Report

    Report Number
    1038671-2025-03284
    Event Type
    Injury
    Date Received
    November 6, 2025
    Report Date
    February 19, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: G1.

    Additional Manufacturer Narrative · 0

    D10: 6144836 300-62-03 - STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 3. 5457507 310-61-44 - STEMLESS HUMERAL HEAD 44MM X 17MM X ALPHA. 5410425 314-13-03 - EQUINOXE CAGE GLENOID MEDIUM, ALPHA. 6036027 315-35-00 - GLND KWIRE. 6123752 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM. 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 UNDERWENT AN INITIAL TSA (TOTAL SHOULDER ARTHROPLASTY) ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A TORN ROTATOR CUFF RESULTING IN THE DEVICES BEING EXPLANTED AND THE PATIENT BEING REVISED TO A COMPETITOR'S DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385879 EQUINOXE PRIMARY SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization SEE H11.