BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 20334918 · Received September 30, 2024

    Report

    Report Number
    1038671-2024-03748
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    March 25, 2024
    Report Date
    July 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA): A375751. 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S: A219430. 308-12-00 - MED PROX BODY +12.5: A054195. 308-15-12 - TAPER LOCKING SCREW 12.5: A111308. 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT: A777714. 308-05-24 - DISTAL FIXATION RING HA 24.5: 6843575. 308-01-06 - 6X80MM DISTAL STEM MODULAR CEMENTED: A430101. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: A465898.

    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/D2A/D2B, H6 . MDR SECTION CODES UPDATED/CORRECTED: B, C, D, G. THE REASON FOR THE REPORTED REVISION DUE TO DISLOCATION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, ROTATOR CUFF FAILURE, 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

    APPROXIMATELY 17 DAY(S) POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A DISLOCATION. PATIENT PRESENTED TO CLINIC TODAY WITH AN ANTERIOR DISLOCATION OF THE SHOULDER. THE PATIENT UNDERWENT A REDUCTION PROCEDURE IN THE CLINIC AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603677 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention SEE H11.