BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21048035 · Received December 31, 2024

    Report

    Report Number
    1038671-2024-05101
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    October 26, 2024
    Report Date
    August 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM: 5210621; 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0: 5276203; 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 5275272; 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE: 5277850; 320-15-01 - EQ REV GLENOID PLATE: 5239409. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE PAIN REPORTED IN CASE-(B)(4) CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION, COMPONENT LOOSENING, COMPONENT SIZING, POSITIONING, OR IMPINGEMENT ISSUES, OR A COMBINATION OF THE ABOVE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. D1: CORRECTED H6: CORRECTED INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    APPROXIMATELY 6 YEAR(S), 7 MONTH(S) AND 14 DAY(S) POST-OPERATIVE OF AN INITIAL RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED UNEXPLAINED PAIN. PAIN STARTED WITH NO REPORTED METHOD OF INJURY. THE PATIENT IS SCHEDULED FOR CT SCAN AND THE OUTCOME REMAINS CONTINUING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134309 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other SEE H11.