BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUP/POST AUG PLATE, R RS GLENOID BASEPLATE

    MDR report key: 18197013 · Received November 22, 2023

    Report

    Report Number
    1038671-2023-02851
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    October 26, 2023
    Report Date
    April 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862242563
    PMA / PMN Number
    K131575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    USER-RELATED CONSIDERATIONS: THERE WERE NO USER-RELATED ISSUES REPORTED THAT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT. PATIENT-RELATED CONSIDERATIONS: THERE ARE NO PATIENT CONDITIONS REPORTED THAT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF GLENOID LOOSENING. THE REPORTED GLENOID LOOSENING COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6 CLINICAL CODE.

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: (B)(6) - 300-30-07 - EQUINOXE PRESERVE STEM 7MM, (B)(6) - 315-35-00 - GLND KWIRE, (B)(6) - 315-35-00 - GLND KWIRE, (B)(6) - 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE 6198913 - 320-10-00 - EQUINOXE REVERSE, TRAY ADAPTER PLATE TRAY +0, (B)(6) - 320-15-05 - EQ REV LOCKING SCREW, (B)(6) - 320-15-08 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE, (B)(6) - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6166816 - 320-20-30 - EQ REV COMPRESS, SCREW LCK CAP KIT, 4.5 X 30MM, (B)(6) - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, (B)(6) - 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM, (B)(6) - 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM , (B)(6)- 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0 5994207 - 321-20-00 - EQUINOXE, REVERSE SHOULDER DRILL KIT.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT RTSA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO GLENOID LOOSENING AND EVIDENCE OF NOTCHING. THERE WAS NO REPORTED BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041279 SUP/POST AUG PLATE, R RS GLENOID BASEPLATE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862242563

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention