BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8662695 · Received June 3, 2019

    Report

    Report Number
    1038671-2019-00319
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 14, 2019
    Report Date
    October 17, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862083876
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) EXPIRATION DATE: 12-JUN-2028 (E3) OCCUPATION: PHYSICIAN (G5) PMA/510(K)NUMBER: K042021. (H3) IT WAS REPORTED THAT A 77 Y/O PATIENT RECEIVED ANATOMIC SHOULDER REPLACEMENT ON (B)(6) 2018. THIS SHOULDER WAS REVISED TO A REVERSE SHOULDER ON (B)(6) 2019 DUE TO OSTEOARTHRITIC CHANGES OF THE SHOULDER. THE PATIENT HAS A HISTORY OF A SIGNIFICANT DEFORMITY. THE PATIENT LEFT THE OR IN STABLE CONDITION. THE DEVICE IS NOT RETURNING. NO FURTHER INFORMATION IS AVAILABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THERE IS NO INDICATION THAT THERE IS A DEVICE RELATED PROBLEM, THERE IS NO ALLEGATION AGAINST THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS RELATED TO THE UNDERLYING PATIENT CONDITIONS. (H4) 14-JUN-2018. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (SECTION F) PLEASE DISREGARD F6 AND F8. THESE WERE ENTERED IN ERROR. (G4) INITIAL AWARENESS DATE IN INITIAL SUBMISSION SHOULD HAVE BEEN 14-MAY-2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES (2): EQUINOXE SQUARE TORQUE DEFINE SCREW DRIVE KIT (CN: 300-20-02; SN: (B)(4)). EQUINOXE REPLICATOR PLATE 1.5MM O/S (CN: 300-10-15; SN: (B)(4)).

    Description of Event or Problem · 1

    PRIMARY SURGERY: (B)(6) 2018. REVISION DUE TO OSTEOARTHRITIC CHANGES OF THE SHOULDER. PATIENT HAS SIGNIFICANT DEFORMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456559 EQUINOXE EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA) KWT EXACTECH, INC. 10885862083876

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention