BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM HUMERAL LINER +0

    MDR report key: 14880992 · Received June 30, 2022

    Report

    Report Number
    1038671-2022-00750
    Event Type
    Injury
    Date Received
    June 30, 2022
    Date of Event
    June 20, 2022
    Report Date
    August 30, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    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

    CUSTOMER SENT EXPLANTED DEVICE TO BIO ENGINEERING FOR ANALYSIS. CONCOMITANTS: 300-01-13 EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM- 7113985; 320-20-00 EQ REVERSE TORQUE DEFINING SCREW KIT- 7151324; 320-10-00 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0- 7012819; 320-15-05 EQ REV LOCKING SCREW- 7236899; 320-01-38 EQUINOXE REVERSE 38MM GLENOSPHERE- 6818376; 320-15-07 SUP/POST AUG PLATE, L RS GLENOID BASEPLATE- 5899654.

    Additional Manufacturer Narrative · 0

    H2: 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 IMPINGEMENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED A (B)(6) MALE PATIENT, LEFT SHOULDER INITIALLY IMPLANTED ON (B)(6) 2022, HAD GREATER TUBEROSITY IMPINGEMENT. ON (B)(6) 2022, THE SURGEON PERFORMED A SERIES OF RELEASES AND SWAPPED THE POLY LINER. SURGEON REPLACED THE POLY LINER FOR A CONSTRAINED OPTION AND INCREASED THE HEIGHT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401976 EQUINOXE REVERSE 38MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER KWT EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention SEE H10.