BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENT

    MDR report key: 15546312 · Received October 5, 2022

    Report

    Report Number
    1038671-2022-01251
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    September 8, 2022
    Report Date
    October 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862534972
    PMA / PMN Number
    K180632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    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 SHOULDER INSTABILITY AND 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, APPROXIMATELY 1YEAR POST OP THE INITIAL LEFT TSA, THIS 71 Y/O FEMALE PATIENT WAS REVISED DUE TO STATING SHOULDER FEELING LIKE IT WAS LOOSE. THERE WERE NO REPORTED ISSUED DURING THE SURGICAL REVISION. THE PATIENT WAS REVISED AND DEEMED TO BE STABLE. THE DEVICE WAS NOT RETURNED DUE TO HOSPITAL POLICY. NEW INFORMATION ON 27 SEP 2022: THE PATIENT HAD JOINT LAXITY. NO COMPONENTS WERE LOOSE. NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 300-30-09 - EQUINOXE PRESERVE STEM 9MM 6938075, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6992287, 320-15-05 - EQ REV LOCKING SCREW 7003748, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6954164, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S290132, 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM S267510, S268670, 320-35-07 - SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT 6149568, 320-40-00 - HUMERAL LINER, 40MM, +0 6196798, 531-20-00 - SHLDR GPS RVRS DRILL KIT 6610764, 531-78-20 - SHOULDR GPS HEX PINS KIT 6825489, A10012 - GPS IMPLANT KIT V2 04078521047.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 YEAR POST OP THE INITIAL LEFT TSA, THIS 71 Y/O FEMALE PATIENT WAS REVISED DUE TO STATING SHOULDER FEELING LIKE IT WAS LOOSE. THERE WERE NO REPORTED ISSUED DURING THE SURGICAL REVISION. THE PATIENT WAS REVISED AND DEEMED TO BE STABLE. THE DEVICE WAS NOT RETURNED DUE TO HOSPITAL POLICY. NEW INFORMATION ON 27 SEP 2022: THE PATIENT HAD JOINT LAXITY. NO COMPONENTS WERE LOOSE. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1YEAR POST OP THE INITIAL LEFT TSA, THIS 71 Y/O FEMALE PATIENT WAS REVISED DUE TO SHOULDER FEELING LIKE IT WAS LOOSE. PATIENT REPORTED SHOULDER FEELING LIKE IT WAS LOOSE. REVISED AND DEEMED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076517 EQUINOXE PRIMARY SHOULDER COMPONENT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-31-40 UNK 10885862534972

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention SEE H10