BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 18882331 · Received March 11, 2024

    Report

    Report Number
    1038671-2024-00463
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 14, 2024
    Report Date
    June 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086747
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 7167729 - 300-30-08 - EQUINOXE PRESERVE STEM 8MM A751583 - 315-35-00 - GLND KWIRE A768084 - 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A795912 - 320-10-46 - GLENOSPHERE 46X21MM INSET A816301 - 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG A750358 - 320-15-05 - EQ REV LOCKING SCREW A771406 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT S446188 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S468649 -320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S418002 - 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 66 YO MALE PATIENT, INITIAL LEFT REVERSE SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE PATIENT PRESENTED TO THE SURGEON DUE TO A DISLOCATION. THE SURGEON SCHEDULED A REVISION. DURING THE PROCEDURE, THE SURGEON REMOVED THE LINER AND GLENOSPHERE, AND IMPLANTED A STD 46 GLENOSPHERE AND THEN TRIALED A +0, +2.5, +5 46 LINER AND FOUND THAT THE +5 BUILD UP TO BE THE MOST STABLE. HE IMPLANTED THE FINAL IMPLANTS AND REDUCED THE SHOULDER. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE EVENT. NO X-RAYS WERE PROVIDED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THE HOSPITAL KEPT THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723919 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +2.5 UNK 10885862086747

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention SEE H10