BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 16723646 · Received April 12, 2023

    Report

    Report Number
    1038671-2023-00655
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    March 20, 2023
    Report Date
    May 28, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086396
    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 INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 0

    DEVICE PENDING EVALUATION. CONCOMITANT DEVICE(S): A128631 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; A046605 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; 7295094 320-15-01 - EQ REV GLENOID PLATE; A117518 320-15-05 - EQ REV LOCKING SCREW; A122310 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT; A156946 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; A157078 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; S368394 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; A118401 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; A141088 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; A123385 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0; 6929600 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT; A010819 321-52-09 - 3.2MM K-WIRE, TROCAR TIP; A010928 321-52-09 - 3.2MM K-WIRE, TROCAR TIP.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6 MONTHS POST OP THE INITIAL LEFT TSA, THIS 66 Y/O MALE PATIENT WAS REVISED DUE INFECTION. NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTOS ATTACHED, UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - SURGEON TOOK IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204504 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862086396

    Patients

    Seq Age Sex Outcome Treatment
    1