BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRESERVE STEM 8MM

    MDR report key: 23406079 · Received October 28, 2025

    Report

    Report Number
    1038671-2025-03218
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    August 5, 2025
    Report Date
    October 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K162726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 322-42-03 - 145-DEG PE 42MM HUM LINER +2.5: B027203. 320-10-10 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10. 320-06-42 - GLENOSPHERE 42MM: B111590. 320-15-01 - EQ REV GLENOID PLATE: B118338. 320-15-05 - EQ REV LOCKING SCREW: A971415. 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 A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC HUMERAL LOOSENING. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION APPROXIMATELY 11 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125741 EQUINOXE PRESERVE STEM 8MM PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11