BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13580978 · Received February 22, 2022

    Report

    Report Number
    1038671-2022-00215
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    February 1, 2022
    Report Date
    August 15, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086587
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION CONCOMITANT DEVICE(S): EQUINOXE REVERSE ADAPTER PLATE TRAY +5 - 320-10-05, 6230354, EQUINOXE REVERSE 38MM GLENOSPHERE - 320-01-38, 6747870, EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 - 320-38-03, S130656, EQ REV LOCKING SCREW - 320-15-05, 6945504, EQ REVERSE TORQUE DEFINING SCREW KIT - 320-20-00, 6926688, EQUINOXE, HUMERAL PRIMARY, PRESS FIT 9MM - 300-01-09, 5824106, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM - 320-20-30, S270960, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM - 320-20-30, S210714, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM - 320-20-34, S213651, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM - 320-20-34, S222422, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM - 320-20-42, S117060, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM - 320-20-42, 6287728.

    Additional Manufacturer Narrative · 0

    (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF INSUFFICIENT FIXATION BETWEEN THE IMPLANTS AND THE BONES AND PATIENT-RELATED CONDITIONS, INCLUDING MULTIPLE PROCEDURES/REVISIONS ON THE INVOLVED SHOULDER, WHICH LED TO ASEPTIC (NON-INFECTED) HUMERAL AND GLENOID LOOSENING AND SUBSEQUENT COMPRESSION SCREW FRACTURE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) MEDICAL DEVICE PROBLEM CODE: 4002, LOOSENING OF IMPLANT NOT RELATED TO BONE-INGROWTH.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMAL 7 MONTHS POST OP LEFT SHOULDER REPLACEMENT, THIS (B)(6) FEMALE PATIENT WAS REVISED FOR A SECOND TIME DUE TO PAIN AND INSTABILITY. THERE WAS LOOSENING OF THE GLENOID AND HUMERAL COMPONENTS WITH IMPLANT BREAKAGE (ONE OF THE BASEPLATE SCREWS). PATIENT HAS POOR HEALTH. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SURGEON WAS HAPPY WITH THE REVISION RESULT. DEVICES WILL NOT BE RETUNING DUE TO THE HOSPITAL DISPOSING OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686311 EQUINOXE REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM KWT EXACTECH, INC. 320-20-42 UNK 10885862086587

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| R SEE H10.