BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM GLENOSPHERE

    MDR report key: 15499900 · Received September 28, 2022

    Report

    Report Number
    1038671-2022-01181
    Event Type
    Injury
    Date Received
    September 28, 2022
    Date of Event
    August 17, 2022
    Report Date
    January 15, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE SERVICED BY A THIRD PARTY?: NO DEVICE RETURNING AS IT WAS DISPOSED OF BY THE FACILITY. CONCOMITANTS MEDICAL PRODUCTS: 320-15-01, 7327696 - EQ REV GLENOID PLATE; 320-42-00, A001741 - EQUINOXE REVERSE 42MM HUMERAL LINER +0; 320-10-00, A010020 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; 320-15-05, A024320 - EQ REV LOCKING SCREW; 320-20-00, A014148 - EQ REVERSE TORQUE DEFINING SCREW KIT; 300-01-15, 7070989 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS, HAVE BEEN UPDATED ACCORDINGLY: H6: 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 PATIENT CONDITIONS. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WHO HAD AN INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2022, HAD THEIR REVERSE SHOULDER REMOVED FOR INFECTION. THE SURGEON PUT IN A DEFINITIVE SPACER USING OUR STEM, REPLICATOR PLATE, TORQUE SCREW AND HUMERAL HEAD. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING AS IT WAS DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921928 EQUINOXE REVERSE 42MM GLENOSPHERE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SEE H10