BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12830204 · Received November 17, 2021

    Report

    Report Number
    1038671-2021-00623
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    October 26, 2021
    Report Date
    June 23, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086396
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 300-01-13, 6649437 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM, 320-10-00, 6781467 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 320-15-04, 6703984 - RS GLENOID PLATE POST AUG, 8 DEG, RIGHT 320-15-04 6703984, 320-15-05, 6746529 - EQ REV LOCKING SCREW, 320-20-00, 6807769 - EQ REVERSE TORQUE DEFINING SCREW KIT, 320-20-42, 5987400 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM, 320-20-46, 4506240 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM, 320-42-00, S122247 - EQUINOXE REVERSE 42MM HUMERAL LINER +0.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 8 MONTHS POSTOP THE INITIAL RIGHT TSA, THE (B)(6) MALE PATIENT PRESENTED WITH INTERMITTENT DRAINING WOUND SINUS. TREATED CONSERVATIVELY INITIALLY, NO BUG GROWN. SURGEON DECIDED TO PERFORM TWO STAGE REVISION, ALL IMPLANTS REMOVED. EVIDENCE OF INFECTION PRESENT. DEVICES NOT RETURNING, SENT TO RPH FOR ANALYSIS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730994 EQUINOXE REVERSE 42MM GLENOSPHERE KWT EXACTECH, INC. 320-01-42 UNK 10885862086396

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| H