BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 46MM GLENOSPHERE

    MDR report key: 20351873 · Received October 2, 2024

    Report

    Report Number
    1038671-2024-03784
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086402
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 320-15-01 - EQ REV GLENOID PLATE (B)(6). 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT (B)(6). 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (B)(6). 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (B)(6). 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM (B)(6). 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM (B)(6). 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT (B)(6). 320-15-05 - EQ REV LOCKING SCREW (B)(6).

    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. THE REVISION REPORTED WAS LIKELY DUE TO DISASSEMBLY BETWEEN THE HUMERAL LINER AND HUMERAL TRAY LEADING TO SUBSEQUENT UNINTENDED METAL-ON-MEAL ARTICULATION BETWEEN COMPONENTS. HOWEVER, MIGRATION OF THE LINER SUBSEQUENT TO THE DISASSEMBLY, AND THE SEQUENCE OF EVENTS COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT, AN UNREPORTED TRAUMATIC EVENT, INCOMPLETE SEATING OF THE HUMERAL LINER DURING IMPLANTATION, FORCEFUL CONTACT BETWEEN THE LINER AND GLENOID BONE (SCAPULAR NOTCHING), OR A COMBINATION OF THE ABOVE TO THE DISASSEMBLY OF THE HUMERAL LINER CANNOT BE CONFIRMED FROM THE REPORTED INFORMATION, AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. 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 THIS PATIENT HAD A RIGHT REVERSE SHOULDER PUT IN 2020. REVISED AGAIN IN 2021 BY A LOCAL ORTHOPEDIC SURGEON. THEN PATIENT SAW A DIFFERENT SURGEON WHO REVISED THE PATIENT AND TOOK OUT HUMERAL COMPONENTS AND GLENOSPHERE AND REPLACED. THERE WAS A LOT OF MATELLOSIS AND THE TRAY WAS COMPLETELY SHEERED OFF THE STEM. THE STEM HAD OVERSTUFFED THE JOINT, A 15 PRESERVE STEM WAS USED. THE SURGEON COULD NOT FIND THE LINER POLY FROM THE ORIGINAL SURGERY. SURGEON CHECKED AROUND THE JOINT FOR IT AS WELL AS HIS PA AND ASSIST. NO ONE COULD FEEL FOR THE 46 +2.5MM LINER IN THE JOINT. PATIENT WAS REVISED TO A FX STEM AND A NEW GLENOSPHERE AND TRAY AND LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTOS, X-RAYS, AND EBI ATTACHED. PRODUCT NOT RETURNING: RISK MANAGER AT THIS FACILITY WILL NOT RELEASE IMPLANTS TO ME. ONLY RELEASE TO PATIENT. BUT I DO HAVE PICTURES. 300-30-15 EQUINOXE PRESERVE STEM 15MM (B)(6). UDI NUMBER (B)(4). 510(K) NUMBER K162726. PRODUCT CODE PHX, KWS, HSD, KWT. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 (B)(6). UDI NUMBER (B)(4). 510(K) NUMBER K063569. PRODUCT CODE KWT. 320-46-03 - 145-DEG PE 46MM HUM LINER +2.5 (B)(6). UDI NUMBER (B)(4). 510(K) NUMBER K063569. PRODUCT CODE KWT. RECALL NUMBER Z-1424-2024. 320-01-46 - EQUINOXE REVERSE 46MM GLENOSPHERE (B)(6). UDI NUMBER (B)(4). 510(K) NUMBER K063569. PRODUCT CODE KWT. CONCOMITANTS: 320-15-01 - EQ REV GLENOID PLATE (B)(6). 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT (B)(6). 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (B)(6). 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (B)(6). 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM (B)(6). 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM (B)(6). 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT (B)(6). 320-15-05 - EQ REV LOCKING SCREW (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35533 EQUINOXE REVERSE 46MM GLENOSPHERE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086402

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention SEE H11.