BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 22287474 · Received June 18, 2025

    Report

    Report Number
    1038671-2025-02315
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 23, 2025
    Report Date
    September 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 320-08-46 - GLENOSPHERE EXP 46MM +4MM OFFSET: B243162. 320-15-05 - EQ REV LOCKING SCREW: B404495. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: B484936. 322-10-10 - HUMERAL ADAPTER TRAY, +10: B014584. 322-46-00 - 145-DEG PE 46MM HUM LINER +0: B012885. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED 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: B3, D1, D6A/D6B, 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 INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. 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

    IT WAS REPORTED THAT A 61 YO MALE PATIENT, WHO HAD THEIR RIGHT SHOULDER IMPLANTED, UNDERWENT A REVISION PROCEDURE. THE REPORTED INFORMATION INDICATED THE PATIENT HAD FECAL MATTER ON THEIR HANDS AND SCRATCHED THEIR WOUND CAUSING AN INFECTION AND THE SUBSEQUENT REVISION. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787809 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention SEE H11.