BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 18726849 · Received February 16, 2024

    Report

    Report Number
    1038671-2024-00251
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    June 30, 2017
    Report Date
    July 7, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    UNK
    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): 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE: 3854530 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 3961684 320-15-04 - RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT: 3936385 320-15-05 - EQ REV LOCKING SCREW: 3852574 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 3961185 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 3877361 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 3964101 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: 2948571 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: 3919069 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0: 3917002 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 3933780

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. NO EXPLANT DATE. THE REASON FOR THE REPORTED REVISION DUE TO SUSPECTED INFECTION 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 BY THE EQUINOXE SHOULDER STUDY, THE 44 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2015 AND PRESENTED WITH INFECTION, 2 YEAR(S) AND 1 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2017. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. THE REPORT ALSO INDICATES THAT THE NO WAS ACTION TAKEN AND THE OUTCOME OF THIS EVENT IS UNKNOWN. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425312 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male SEE H10