BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 22410837 · Received July 7, 2025

    Report

    Report Number
    1038671-2025-02423
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    November 2, 2017
    Report Date
    July 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 300-01-11 - EQUI HUMERAL STEM PRIMARY, PRESS FIT 11MM: (B)(6). 320-42-03 - EQUI REVERSE 42MM HUMERAL LINER +2.5: (B)(6). 320-10-00 - EQUI REVERSE TRAY ADAPTER PLATE TRAY +0: (B)(6). 320-01-42 - EQUI REVERSE 42MM GLENOSPHERE: (B)(6). 320-15-05 - EQ REV LOCKING SCREW: (B)(6). THE REVISION REPORTED MAY BE THE RESULT OF THE SEPTIC GLENOID LOOSENING AS REPORTED. HOWEVER, THE SERIES OF EVENTS AND CONTRIBUTING FACTORS TO EACH CANNOT BE CONFIRMED AND ANY POTENTIAL CONTRIBUTIONS FROM PATIENT-RELATED CONTRIBUTING FACTORS TO THE EVENT CANNOT BE EVALUATED AS NO RADIOGRAPH, IMAGES, OR CLINICAL INFORMATION WAS PROVIDED. THE REASON FOR THE REPORTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. A REVIEW OF THE STERILE CERTIFICATES FOR ALL EXPLANTED COMPONENTS WAS PERFORMED AND THE STERILE LOTS WERE ACCEPTED TO THE REQUIREMENTS. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. 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

    SUBJECT: (B)(6). AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY TWO MONTHS POST INITIAL TSA, THE 57 Y/O MALE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. THE BASEPLATE BECAME LOOSE EARLY AFTER SURGERY BUT BECAME COMPLETELY DISPLACED AFTER FALL IN (B)(6) 2018. EVENT IS STILL ONGOING, THE SURGEON DISCUSSED REVISION BUT SUBJECT IS OPTING OUT FOR NOW. PER CLINICAL REPORT, THE REPORTED EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. UPDATE 6/26/2025 ML. SUSPECT DEVICE(S): 320-15-07 - SUP/POST AUG PLATE, L RS GLENOID BASEPLATE: (B)(6). UDI: (B)(4). 510K: K131575. PRODUCT CODE: KWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897739 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11.