BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER COMPONENTS

    MDR report key: 18109242 · Received November 10, 2023

    Report

    Report Number
    1038671-2023-02736
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    August 24, 2023
    Report Date
    September 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B5) CORRECTED ORIGINAL DESCRIPTION AND ADDED REVISION INFORMATION. (D6B) ADDED EXPLANT DATE.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: A082786 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; 6418254 310-01-38 - EQUINOXE, HUMERAL HEAD SHORT, 38MM (ALPHA) 7288542 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, D4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, F, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND PAIN 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. 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

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2023. THE PATIENT PRESENTED ON (B)(6) 2023 WITH PAIN. HAD PAIN/INSTABILITY SINCE AND PATIENT REPORTS AN UNEXPLAINED INCREASED PAIN AND DECREASED FUNCTION. CT SCAN ORDERED; COMPONENTS ARE WELL PLACED, POSSIBLE SUBSCAPULARIS TEAR. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. THE OUTCOME OF THIS EVENT IS RESOLVED BY STANDARD TOTAL REVISION ON (B)(6) 2024.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2023. THE PATIENT PRESENTED ON (B)(6)2023 AND (BRIEFLY DESCRIBE ADVERSE EVENT) HAD AN INITIAL DISLOCATION WHILE DRINKING THAT SPONTANEOUSLY REDUCED IN CAR. HAD PAIN/INSTABILITY SINCE AND PATIENT REPORTS AN UNEXPLAINED INCREASED PAIN AND DECREASED FUNCTION. CT SCAN ORDERED; COMPONENTS ARE WELL PLACED, POSSIBLE SUBSCAPULARIS TEAR. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT TO DEVICE, POSSIBLY RELATED TO PROCEDURE. OUTCOME: CONTINUING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945207 UNKNOWN SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention