BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 24545107 · Received March 9, 2026

    Report

    Report Number
    1038671-2026-00237
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    June 3, 2025
    Report Date
    March 9, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 300-01-14 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 14MM B330372. 320-08-42 - GLENOSPHERE EXP 42MM +4MM OFFSET B093208. 320-15-01 - EQ REV GLENOID PLATE B417806. 320-15-05 - EQ REV LOCKING SCREW B313204. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT B449618. 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM B231915. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM B401273. 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM B152259. 322-10-00 - HUMERAL ADAPTER TRAY, +0 B427187 322-42-03 - 145-DEG PE 42MM HUM LINER +2.5 B272504. 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE B278803. 531-78-20 - SHOULDR GPS HEX PINS KIT B292588. A10012 - GPS IMPLANT KIT V2 11000124123. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 2 MONTHS AND 28 DAYS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED TO THE CLINIC WITH PAIN AND LABS SHOWED INFECTION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR INCISION AND DRAINAGE IN THE SHOULDER AREA - DEEP ABSCESS OR HEMATOMA, AND IMPLANT OF NON-BIODEGRADE IMPACT ANTIBIOTIC BEADS AND ANTIBIOTIC ELUTING DEVICE I THE PROXIMAL HUMERUS. DURING THE OPERATION THE DECISION FOR A REVISION WAS MADE. THE PATIENT SHOWED UP AT POST-OP FOLLOW UP WITH CLEAN LABS AND NO PAIN. THE OUTCOME IS CONSIDERED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29776 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization| R SEE H11.