BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8767837 · Received July 8, 2019

    Report

    Report Number
    1038671-2019-00362
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    June 12, 2019
    Report Date
    October 18, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862186768
    PMA / PMN Number
    K110708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (E3) OCCUPATION: PHYSICIAN (G5) PMA/510(K)NUMBER: K110708 (H3) IT WAS REPORTED THAT THIS 75 YEAR OLD PATIENT WAS IMPLANTED WITH THIS REVERSE SHOULDER ON (B)(6) 2019, THEN REVISED ON A UNKNOWN DATE, TO A CONSTRAINED BECAUSE THE PATIENT WAS DISLOCATING. ANOTHER SURGEON REVISED THE SHOULDER ON (B)(6) 2019, BUT BASED ON THE BONE LOSS, ORIGINAL POSITIONING OF THE IMPLANT, AND POTENTIAL INFECTION HE WAS UNABLE TO REPAIR ANY DAMAGE. NO IMPLANTS WERE PLACED IN THE PATIENT. THE PATIENT WAS STABLE AS THEY LEFT THE OR. THE DEVICES ARE 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. 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 12-JUN-2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICES: 320-15-01, 10241308, BASEPLATE; 320-15-05, GLENOSPHERE LOCKING SCREW; 320-20-00, 98104001, TORQUE SCREW; 320-10-00, 49063521, 0+ TRAY; 320-42-13, 42MM CONSTRAINED LINER; 320-20-34, 34MM SCREW; 320-20-30, 30MM SCREW; 320-20-38, 38MM SCREW; 320-20-34, 34MM SCREW; 320-20-34, 34MM SCREW.

    Description of Event or Problem · 1

    DOCTOR REVISED THE SHOULDER BUT BASED ON THE BONE LOSS, ORIGINAL POSITIONING OF THE IMPLANT, AND POTENTIAL INFECTION HE WAS UNABLE TO REPAIR THE DAMAGE. NO IMPLANTS WERE PLACED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560763 EQUINOXE RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET KWT EXACTECH, INC. 10885862186768

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention