BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 22394877 · Received July 3, 2025

    Report

    Report Number
    1038671-2025-02419
    Event Type
    Injury
    Date Received
    July 3, 2025
    Report Date
    September 3, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6, H11. 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; HOWEVER, MAY HAVE RESULTED FROM UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. 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

    D10 B163300 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT. B168409 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. B186770 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. B226347 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. B263335 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM. B269504 320-15-05 - EQ REV LOCKING SCREW. B306741 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. B307145 320-15-01 - EQ REV GLENOID PLATE. B309432 320-38-00. H3: THE REASON FOR THE REPORTED REVISION DUE TO SUSPECTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S SHOULDER PROTHESIS BECAME INFECTED 2 MONTHS POST INITIAL OPERATION. PATIENT WAS RE-OPENED AND A THOROUGH WASH OUT WAS COMPLETED BEFORE CLOSING, OWING TO NO OBVIOUS SIGNS OF HARDWARE INFECTION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176075 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

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