BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 11751704 · Received April 30, 2021

    Report

    Report Number
    1038671-2021-00207
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 8, 2021
    Report Date
    July 7, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086716
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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): 300-30-12, 5844380 - EQUINOXE PRESERVE STEM 12MM. 320-02-42, 6709501 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET. 320-10-00, 6763200 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-15-05, 6832873 - EQ REV LOCKING SCREW. 320-20-00, 6789863 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-15-08, 6552558 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE. 320-20-38, 6403533 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 320-20-38, S126143 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 320-20-30, S093392 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM.

    Description of Event or Problem · 1

    AS REPORTED, THIS MALE PATIENT HAD ISSUES WITH AN R SHOULDER INFECTION OVER THE LAST 2 WEEKS SINCE THE INITIAL TSA IMPLANT. THE PATIENT WAS REVISED, AND AN ANTIBIOTIC SPACER WAS PLACED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT, DEVICES WILL NOT RETURN, FACILITY DISPOSED OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652697 EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0 KWT EXACTECH, INC. 320-42-10 UNK 10885862086716

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R