BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 18725841 · Received February 16, 2024

    Report

    Report Number
    1038671-2024-00250
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    February 21, 2019
    Report Date
    July 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM: 5219781. 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT: 5262240. 300-30-08 - EQUINOXE PRESERVE STEM 8MM: 5202662. 315-35-00 - GLND KWIRE: 5221091. 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE: 5276485. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 5245276. 320-15-03 - RS GLENOID PLATE L POST AUG, 8 DEG, LEFT: 5198916. 320-15-05 - EQ REV LOCKING SCREW: 5256998. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 5133144. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT 4.5 X 22MM: 5238022. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 5240034. 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: 5159346. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 3949712.

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE PATIENT¿S SHOULDER SUBLUXATION AND INSTABILITY REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. SUBLUXATION AND INSTABILITY ARE KNOWN RISKS, AS OUTLINED IN THE IFU. D1: CORRECTED. D4/D6: DEVICE, SERIAL #, UDI #, EXPIRATION, IMPLANT AND EXPLANT DATES UNKNOWN. G3: MANUFACTURED DATES UNKNOWN. G4: PMA 510K CANNOT BE DETERMINED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 62 YEAR OLD MALE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2018 AND PRESENTED WITH INSTABILITY/SUBLUXATION, 1 YEAR(S) AND 0 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2019. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE NO WAS ACTION TAKEN. THE OUTCOME IS REPORTED AS RESOLVED ON (B)(6) 2021. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530172 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male