BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12165679 · Received July 14, 2021

    Report

    Report Number
    1038671-2021-00338
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    June 1, 2021
    Report Date
    November 23, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862186683
    PMA / PMN Number
    K110708
    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

    CONCOMITANT DEVICE(S): EQ REV LOCKING SCREW , 320-15-05 ,4991276; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 320-10-00, 4981937; EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM, 300-01-11, 4977661; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM , 320-20-26, 4911197; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM , 320-20-26 , 4993230; EQ REVERSE TORQUE DEFINING SCREW KIT , 320-20-00 , 4981183; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM , 320-20-30, 4988776; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM , 320-20-26, 4911347; RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET , 320-02-42 , 4989979; EQUINOXE REVERSE 42MM HUMERAL LINER +0 , 320-42-00 ,4958961.

    Description of Event or Problem · 1

    AS WAS REPORTED, APPROXIMATELY 3.2 YRS POSTOP THE INITIAL L TSA, THIS (B)(6) Y/O MALE PATIENT WAS REVISED. EVERYTHING WAS REMOVED AND A CEMENT SPACER WAS INSERTED DUE TO INFECTION. AFFECTED. THIS PRODUCT IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062353 EQUINOXE RS GLENOID PLATE L POST AUG, 8 DEG, LEFT KWT EXACTECH, INC. 320-15-03 UNK 10885862186683

    Patients

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