BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 18297942 · Received December 8, 2023

    Report

    Report Number
    1038671-2023-02950
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    November 23, 2023
    Report Date
    April 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A2 D8 H6 THE FOLLOWING SECTIONS WERE CORRECTED: B2 D1: BRAND NAME CORRECTED. CATALOG NUMBER EXPIRATION DATE AND SERIAL NUMBER UNKNOWN G4: 510K IS UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED H4: MANUFACTURE DATE IS UNKNOWN H6 A REVIEW OF THE STERILE CERTIFICATES AND/OR THE FINAL ENDOTOXIN TEST REPORTS WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO AN 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION.

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 7116228 - 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM. 7241063 - 315-35-00 - GLND KWIRE. 6759418 - 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE 7215157 - 320-10-00 - EQUINOXE. REVERSE TRAY ADAPTER PLATE TRAY +0. 7196191 - 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG. 7237501 - 320-15-05 - EQ REV LOCKING SCREW. 7255219 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT S337578 - 320-20-18 - EQ REV. COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. S342677 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. S315904 - 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. S327568 - 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM. S333444 - 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0 6801395 - 321-20-00 - EQUINOXE. REVERSE SHOULDER DRILL KIT.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO INFECTION. THE IMPLANTS WERE REMOVED AND REPLACED WITH 48MM SPACERS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274052 EQUINOXE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| R SEE H10.