BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ REV GLENOID PLATE

    MDR report key: 15968593 · Received December 13, 2022

    Report

    Report Number
    1038671-2022-01592
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    November 18, 2022
    Report Date
    March 23, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086488
    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

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 7279827, 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; 7111264, 315-35-00 - GLND KWIRE; 7063977, 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE; 7163530, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; 7312636, 320-15-05 - EQ REV LOCKING SCREW; 7282105, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT; S260774, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; S291182, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; S357991, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; S348365, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; 6451179, 320-42-13 - EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5.

    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 SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS (PREVIOUS JOINT INFECTION), UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 6 MONTHS POST OP TSA, THIS MALE PATIENT WAS REVISED DUE TO INFECTION. PATIENT HAD A PREVIOUS REVISION SURGERY, CAPTURED IN CASE (B)(4) (1038671-2022-00198), WHICH WAS ALSO DUE TO INFECTION. AS THE RESULT, SURGEON REMOVED ALL EXACTECH IMPLANTS FROM PATIENT. AFTER EXPOSING THE JOINT THE HUMERAL SIDED IMPLANTS WERE LOOSE (CEMENTED IN) AND WERE EASILY REMOVED. THE GLENOID WAS WELL FIXED BUT A LARGE AMOUNT OF PUS WAS SEEN BEHIND THE GLENOSPHERE. THE GLENOID BASEPLATE WAS REMOVED EASILY ENOUGH WITH A SLAP HAMMER WITHOUT SIGNIFICANT BONE LOSS. THIS WAS A STAGED REVISION WHERE PARTS WERE ONLY REMOVED AND NOT REIMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. DEVICES WILL NOT BE RETURNING, DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146756 EQ REV GLENOID PLATE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-15-01 UNK 10885862086488

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10