BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 19213889 · Received April 30, 2024

    Report

    Report Number
    1038671-2024-01013
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    May 3, 2023
    Report Date
    July 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Removal / Correction Number
    Z-1422-2024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM : 6613063 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET : 6669891 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 : 6728154 320-15-01 - EQ REV GLENOID PLATE : 6588671 320-15-05 - EQ REV LOCKING SCREW : 6683013 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT : 6687524 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM : S083862 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM : S086662 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM : S094873 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT : 6714598. (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS B5, D6B, G1, G3, G6, H1, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY.

    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, D4, G4, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION 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 BY THE EQUINOXE SHOULDER STUDY, THE 63-YEAR-OLD WHITE MALE HAD A LEFT TSA (B)(6) 2020. THE PATIENT PRESENT WITH DISLOCATION ON (B)(6) 2023. THE PATIENT DISLOCATED HIS PROSTHESIS MOVING A CHAIR. THE ACTION TAKEN WAS OTHER ¿ GAVE EXERCISES AND THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 63-YEAR-OLD WHITE MALE HAD A LEFT TSA IMPLANTED ON (B)(6) 2020 AND PRESENT WITH DISLOCATION ON (B)(6) 2023. THE PATIENT DISLOCATED HIS PROSTHESIS MOVING A CHAIR. THE PATIENT WAS GIVEN EXERCISES AND THEN UNDERWENT STANDARD REVERSE REVISION SURGERY ON (B)(6) 2024, IN WHICH THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW COMPONENTS WERE REMOVED. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170991 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male SEE H10