BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12172383 · Received July 15, 2021

    Report

    Report Number
    1038671-2021-00342
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    June 22, 2021
    Report Date
    November 21, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086488
    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 DISLOCATION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND THE RESULT OF LOOSENED SUPPORTING LIGAMENTS AND MUSCLES, WHICH ALLOWED FOR DISLOCATION OCCURRING DUE TO THE SIGNIFICANT LIGAMENT RECONSTRUCTION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (SECTION F10) PLEASE DISREGARD HEALTH EFFECT - IMPACT CODES. THESE WERE ENTERED IN ERROR.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): COMPRESSION SCREW, 4.5 X 34MM, 320-20-34, 4785359. COMPRESSION SCREW, 4.5 X 30MM, 320-20-30 , 4772173. TORQUE DEFINING SCREW KIT 320-20-00, 4912242. HUMERAL LINER, 38MM, + 320-38-00, 4942918. COMPRESSION SCREW, 4.5 X 22MM 320-20-22, 4944440. 10.5MM PLATFORM FX STEM RIGHT 304-22-11, 4577575. HUMERAL ADAPTER TRAY 320-10-00, 4957114. HUMERAL LINER, 38MM, 320-38-03 , 4757298. GLENOSPHERE LOCKING SCREW 320-15-05, 4927802. COMPRESSION SCREW, 4.5 X 34MM, 320-20-34, 4308393. 2.0MM & 3.2MM DRILL BIT 321-20-00, 4710750. GLENOSPHERE, 38MM 320-01-38, 4854880.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 4 YRS POSTOP THE INITIAL R TSA, THE (B)(6) Y/O FEMALE PATIENT WAS REVISED FOR DISLOCATION. UPON INSPECTING THE PROSTHESIS, THE FRACTURE STEM AND CEMENT WERE UNSTABLE, SO THE SURGEON REMOVED THEM AND REPLACED WITH HRP. INCREASED THE GLENOSPHERE TO A 42MM AND CONSTRAINED LINER. DEVICES WERE DISPOSED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074810 EQUINOXE REV GLENOID PLATE KWT EXACTECH, INC. 320-15-01 UNK 10885862086488

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Hospitalization| R SEE H10