BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 24236054 · Received February 2, 2026

    Report

    Report Number
    1038671-2026-00109
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    January 13, 2021
    Report Date
    February 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. D10: 300-30-08 - EQUINOXE PRESERVE STEM 8MM 6691367 315-35-00 - GLND KWIRE 6749053 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6773877 320-15-05 - EQ REV LOCKING SCREW 6413940 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6766077 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S201774 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM S202431 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM S202102 320-31-36 - GLENOSPHERE, 36MM 6699399 320-35-08 - SMALL SUPERIOR/POSTERIOR AUGGLENOID PLATE,RIGHT 6718109 320-36-00 - 145-DEG PE 36MM HUM LINER +0 6675863.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER ARTHROPLASTY. FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED SENSORIMOTOR DEFICIENCIES INCLUDING BRACHIAL PLEXUS WEAKNESS AFFECTING THE DELTOID AND BICEPS. SUBSEQUENTLY, THE PATIENT DIED DUE TO UNRELATED ISSUES, BUT THE OUTCOME WAS STILL BEING FOLLOWED AT THE TIME OF THE SUBJECT'S DEATH IN THE SCOPE OF SUBJECT'S ALS PROGRESSION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294347 EQUINOXE REVERSE SHOULDER COMPONENTS SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization