BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8659226 · Received May 31, 2019

    Report

    Report Number
    1038671-2019-00312
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    April 19, 2019
    Report Date
    October 18, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086396
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE: 15-FEB-2023. OCCUPATION: PHYSICIAN. PMA/510(K)NUMBER: K063569. THIS PATIENT CALLED EXACTECH'S REGULATORY DEPARTMENT TO REPORT THAT SHE WAS GOING TO MOST LIKELY HAVE A REVISION DUE TO A NICKLE ALLERGY OR INFECTION. THERE WAS NO FURTHER CONTACT WITH THE PATIENT WHO DID NOT LEAVE A CONTACT NUMBER. THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THERE IS NO INDICATION THAT THERE IS A DEVICE RELATED PROBLEM, AT THIS TIME THERE DOES NOT APPEAR TO BE RELATED TO THE DEVICES. HOWEVER, THAT COULD NOT BE CONFIRMED DUE TO DEVICES WERE NOT RETURNED AND THE PATIENT ONLY COMMUNICATED LIMITED INFORMATION. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS RELATED TO THE UNDERLYING PATIENT CONDITION WITH ALLERGIES OR INFECTION. DEVICE MANUFACTURE DATE: 19-FEB-2018. CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (SECTION F) PLEASE DISREGARD F6 AND F8. THESE WERE ENTERED IN ERROR. DATE RECEIVED BY MANUFACTURER SHOULD HAVE BEEN 10-MAY-2019 ON INITIAL SUBMISSION.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: 320-15-05 - EQUINOXE REVERSE LOCKING SCREW; 320-20-00 - EQUINOXE REVERSE TORQUE DEFINING SCREW KIT; 320-42-10 - EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0.

    Description of Event or Problem · 1

    REVISION DUE TO POSSIBLE NICKEL ALLERGY OR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452937 EQUINOXE EQUINOXE REVERSE 42MM GLENOSPHERE KWT EXACTECH, INC. 10885862086396

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention