BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 24674563 · Received March 24, 2026

    Report

    Report Number
    1038671-2026-00322
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 24, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 300-30-11 - EQUINOXE PRESERVE STEM 11MM 6860297. 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG B545700. 320-15-05 - EQ REV LOCKING SCREW B795014. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM B749644. 322-10-05 - HUMERAL ADAPTER TRAY, +5 B592054. 322-38-00 - 145-DEG PE 38MM HUM LINER +0 B772042. 320-06-38 - GLENOSPHERE 38MM B517773. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT B812104. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM B806831. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM B807143. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM B807166. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM B807167. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM B816728. 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, DURING AN INITIAL TOTAL SHOULDER REPLACEMENT THE PATIENT EXPERIENCED AN INTRAOPERATIVE GREATER TUBEROSITY FRACTURE DURING DISLOCATION. THE GLENOID WAS REMOVED AND THE PATIENT WAS CONVERTED FROM A TOTAL SHOULDER ARTHROPLASTY TO A REVERSE TOTAL SHOULDER ARTHROPLASTY. THE OUTCOME IS CONSIDERED TO BE CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736691 EQUINOXE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R SEE H11