BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 22592883 · Received July 24, 2025

    Report

    Report Number
    1038671-2025-02589
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    October 11, 2022
    Report Date
    January 16, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 300-01-11 - EQ HUMERAL STEM PRIMARY, PRESS FIT 11MM: 6255143. 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED:6027681. 320-10-00 - EQUINOXE REVERSE ADAPTER PLATE TRAY +0: 6296863. 320-31-36 - GLENOSPHERE, 36MM: 6141487. 320-35-03 - SMALL POSTERIOR AUGMENT GLENOID PLATE, LEFT: 5930496. 320-15-05 - EQ REV LOCKING SCREW: 6286860. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION: PLEASE DISREGARD THIS REPORT AS IT WAS SUBMITTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT # 1038671-2022-01344

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6 . MDR SECTION CODES UPDATED/CORRECTED: B, C, D. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. 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 REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DISLOCATION. PATIENT WAS SITTING ON THE COUCH WHEN SHOULDER DISLOCATED WHILE TRYING TO STAND UP .AS A RESULT, ALMOST 3 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION AND WAS REVISED TO HEMIARTHROPLASTY. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859694 EQUINOXE REVERSE SHOULDER COMPONENTS SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| H