BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12575802 · Received October 5, 2021

    Report

    Report Number
    1038671-2021-00515
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    September 9, 2021
    Report Date
    July 15, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079312
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    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 MOST LIKELY CAUSE OF THE REPORTED EVENT WAS PATIENT CONDITIONS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE(S): 320-01-38, 5194638 - EQ 38MM GLENOSPHERE; 320-10-00, 5203311 - EQ ADAPTER PLATE TRAY +0; 320-15-05, 5206990 - EQ REV LOCKING SCREW; 320-20-00, 5200989 - EQ REVERSE TORQUE DEFINING SCREW KIT; 320-20-18, 5159008 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; 320-20-26, 4873182 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; 320-20-34, 5173454 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; 320-20-34, 5148351 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 3 YRS POSTOP THE INITIAL LTSA, THIS (B)(6) Y/O FEMALE PATIENT WAS REVISED DUE THE HUMERUS HAD ERODED AWAY OVER TIME TO THE POINT OF NEEDING AN HRP. DEVICES WILL NOT RETURN DUE TO FACILITY POLICY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476152 EQUINOXE HUMERAL STEM PRIMARY, PRESS FIT 11MM KWT EXACTECH, INC. 300-01-11 UNK 10885862079312

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Hospitalization| R