BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12294322 · Received August 9, 2021

    Report

    Report Number
    1038671-2021-00376
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    July 15, 2021
    Report Date
    November 24, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086662
    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 · 1

    PENDING EVALUATION CONCOMITANT DEVICE(S): 320-15-01, 6499103 - EQ REV GLENOID PLATE. 320-20-22, 6375277 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. 320-20-30, S080058 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 320-15-05, 6541860 - EQ REV LOCKING SCREW. 320-01-38, 6577322 - EQUINOXE REVERSE 38MM GLENOSPHERE. 300-01-09, 6462739 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM. 320-20-00, 6542365 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-10-00, 6578203 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-20-22, 5979962 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 1 YR POSTOP THE INITIAL L TSA, THE (B)(6) Y/O FEMALE PATIENT HAD A SUSPECTED INFECTION, SO THE SURGEON TOOK SAMPLES AND DID A WASHOUT WITH POLY EXCHANGE. THE PATIENT IS IN STABLE CONDITION. DEVICE WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191322 EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 KWT EXACTECH, INC. 320-38-03 UNK 10885862086662

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R