BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5

    MDR report key: 19153302 · Received April 22, 2024

    Report

    Report Number
    1038671-2024-00920
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    March 21, 2024
    Report Date
    October 27, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086723
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    7033170 - 300-30-11 - EQUINOXE PRESERVE STEM 11MM A149071 - 320-06-42 - GLENOSPHERE 42MM A135617 - 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A163013 - 320-15-05 - EQ REV LOCKING SCREW 6144875 - 320-15-07 - SUP/POST AUG PLATE, L RS GLENOID BASEPLATE A124848 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A166821 - 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM A039019 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM A141012 - 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 6029281 - 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM 6097913 - 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM S336228 - 320-42-00 - 145-DEG PE 42MM HUM LINER +0 (B)(6) - 320-42-13 - 145-DEG PE 42MM CONST HUM LINER +2.5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 81 YO MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 1 YEAR 5 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. BAD POLY INDICATED. THE POLY WAS REPLACED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN. CHAIN OF COMMAND, DUE TO THE RECALL THE HOSPITAL WILL NOT RELEASE IT. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254445 EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086723

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention SEE 10