BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20630925 · Received November 7, 2024

    Report

    Report Number
    1038671-2024-04293
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    October 21, 2024
    Report Date
    May 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY HAVE BEEN THE RESULT OF JOINT INSTABILITY OR HUMERAL LOOSENING AS REPORTED. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO PRODUCT IMAGES OR RELEVANT CLINICAL INFORMATION WAS PROVIDED. D1: CORRECTED. H6: CORRECTED COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANTS: 300-30-06 EQUINOXE PRESERVE STEM 6MM A840667 315-35-00 - GLND KWIRE A933807 320-08-42 - GLENOSPHERE EXP 42MM +4MM OFFSET A475160 320-15-05 - EQ REV LOCKING SCREW B026033 320-15-07 - SUP/POST AUG PLATE, L RS GLENOID BASEPLATE A872599 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT B029241 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S534218 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM A896121 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM S432655 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM S537352 320-42-00 - 145-DEG PE 42MM HUM LINER +0 S468357 322-10-00 - HUMERAL ADAPTER TRAY, +0 A978010 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE A993231 531-78-20 - SHOULDR GPS HEX PINS KIT B048867 A10012 - GPS IMPLANT KIT V2 01013824005.

    Description of Event or Problem · 0

    APPROXIMATELY 3 MONTHS AND 26 DAYS POST-OPERATIVE OF A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA), IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOOSENING OF THE HUMERAL STEM. THE PATIENT UNDERWENT STANDARD REVERSE REVISION FOR INSTABILITY AND THE LOOSE HUMERAL STEM. THE HUMERAL COMPONENTS WERE REMOVED AND THE DOCTOR IMPLANTED A COMPETITOR'S HUMERAL COMPONENTS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO BREAKAGE OR SURGICAL DELAYS WERE REPORTED AND THE DEVICES WILL NOT BE RETURNING AS THEY WERE SENT TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611599 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11