BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12468872 · Received September 14, 2021

    Report

    Report Number
    1038671-2021-00478
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    August 24, 2021
    Report Date
    October 29, 2021
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    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 INSTABILITY AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 320-01-38, 5077112 - EQ 38MM GLENOSPHERE. 320-10-00, 5034425 - EQ REV ADAPTER PLATE TRAY. 320-15-05, 5086949 - EQ REV LOCKING SCREW. 320-20-00, 5133077 - EQ TORQUE SCREW KIT.

    Description of Event or Problem · 1

    AS REPORTED THIS (B)(6) FEMALE PATIENT DEVELOPED LEFT SHOULDER INSTABILITY RECENTLY AND DECIDED TO UNDERGO REVISION SURGERY TO FIX THIS. SURGEON UPSIZED GLENOSPHERE AND LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364003 EQUINOXE REVERSE 38MM HUMERAL LINER +0 KWT 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R SEE H10