BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 19873727 · Received July 31, 2024

    Report

    Report Number
    1038671-2024-02611
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 3, 2024
    Report Date
    August 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 4765538 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE 4989658, 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5. 5117773, 320-15-01 - EQ REV GLENOID PLATE. 5086647, 320-15-05 - EQ REV LOCKING SCREW. 5140898, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. 5127031, ,320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 5131019, ,320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 5138329, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 4911551, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM .5068159, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 4811862, 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM. 4892129, 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0. 5150881 ,321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT.

    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, E, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE PAIN AND SUBSEQUENT REVISION REPORTED WAS LIKELY THE RESULT OF ABNORMAL METAL-ON-METAL ARTICULATION LEADING TO PROSTHESIS WEAR AND METAL DEBRIS. HOWEVER, IT REMAINS UNCLEAR WHICH METAL COMPONENTS WERE ABNORMALLY ARTICULATING WITH EACH OTHER AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO INITIAL POST-OPERATIVE RADIOGRAPHS WERE 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

    AS REPORTED, 6 YEARS 5 MONTHS POST THE INITIAL RIGHT TSA, PATIENT WAS REVISED DUE TO PAIN AND LOSS OF FUNCTION OF HIS RIGHT SHOULDER. THE PATIENT HAD AN EXACTECH REVERSE TSA. ONCE IN THE SHOULDER, THERE WERE CLEAR SIGNS OF METALLOSIS FROM THE DARK BLACK TISSUE AND SIGNS OF OSTEOLYSIS. THE SURGEON EXPLANTED ALL EXACTECH HARDWARE AND REPLACED WITH COMPETITOR IMPLANTS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241025 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention SEE H11.