BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 14166511 · Received April 21, 2022

    Report

    Report Number
    1038671-2022-00443
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    March 31, 2022
    Report Date
    August 25, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086662
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE(S): 320-20-22, S335829 - EQ REV COMPRESS SCREW LCK CAP KIT 4.5MM X 22 MM. 320-15-05, 7246636 - EQ REV LOCKING SCREW. 320-20-00, 7151171 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-08-38, 7123648 - GLENOSPHERE EXP 38MM +4MM OFFSET. 320-10-10, 6886305 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10.

    Additional Manufacturer Narrative · 0

    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 SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: AS REPORTED, THIS 74 Y/O MALE PATIENT'S RIGHT TSA WAS REVISED DUE TO HIS SHOULDER BECOMING UNSTABLE. SURGEON DID A POLY EXCHANGE WITH A LARGER PROXIMAL HUMERAL PLATE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY. NO OTHER INFORMATION WILL BE PROVIDED DUE TO HOSPITAL POLICY. THERE IS NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED, THIS (B)(6) MALE PATIENT'S RIGHT TSA WAS REVISED DUE TO HIS SHOULDER BECOMING UNSTABLE. SURGEON DID A POLY EXCHANGE WITH A LARGER PROXIMAL HUMERAL PLATE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY.

    Description of Event or Problem · 0

    AS REPORTED, THIS 74 Y/O MALE PATIENT'S RIGHT TSA WAS REVISED DUE TO HIS SHOULDER BECOMING UNSTABLE. SURGEON DID A POLY EXCHANGE WITH A LARGER PROXIMAL HUMERAL PLATE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY. NO OTHER INFORMATION WILL BE PROVIDED DUE TO HOSPITAL POLICY. THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920310 EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 KWT EXACTECH, INC. 320-38-03 UNK 10885862086662

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| H SEE H10