BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER COMPONENTS

    MDR report key: 19350359 · Received May 20, 2024

    Report

    Report Number
    1038671-2024-01335
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    April 22, 2024
    Report Date
    August 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: (B)(6) - 300-30-13 - EQUINOXE PRESERVE STEM 13MM. (B)(6) - 315-35-00 - GLND KWIRE. (B)(6) - 320-06-38 - GLENOSPHERE 38MM. (B)(6) - 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. (B)(6) - 32038-03 - EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 6731884 - 320-15-05 - EQ REV LOCKING SCREW. (B)(6) - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6029084 - 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. (B)(6) - 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. (B)(6) - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. (B)(6) - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. (B)(6) - 320-38-03 - 145-DEG PE 38MM HUM LINER +2.5. (B)(6) - 531-20-00 - SHLDR GPS RVRS DRILL KIT. (B)(6) - 531-78-20 - SHOULDR GPS HEX PINS KIT. (B)(6) - 10012 - GPS IMPLANT KIT V2.

    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, D6A, H6 . MDR SECTION CODES UPDATED/CORRECTED: B, C, D, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE REPORTED REVISION DUE TO SUSPECTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. 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, APPROXIMATELY 3 YEARS AND 3 MONTHS POST THE INITIAL LEFT TSA, THE 77 YEAR OLD MALE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO INFECTION. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147491 UNKNOWN SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention SEE H10