BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 11751699 · Received April 30, 2021

    Report

    Report Number
    1038671-2021-00205
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 14, 2021
    Report Date
    May 25, 2021
    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

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE(S): 320-15-04, 6176499 - RS GLENOID PLATE POST AUG, 8 DEG, RIGHT. 320-20-34, 6293941 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 320-20-30, 6285744 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. 320-20-22, 5913362 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. 320-20-26, 6121284 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 320-15-05, 6361198 - EQ REV LOCKING SCREW. 320-01-38, 6313769 - EQUINOXE REVERSE 38MM GLENOSPHERE. 300-01-13, 6330800 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM. 320-10-00, 6322706 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-20-00, 6369268 - EQ REVERSE TORQUE DEFINING SCREW KIT.

    Description of Event or Problem · 1

    AS REPORTED, ON (B)(6) 2021,THIS (B)(6) Y/O MALE PATIENT RETURNED 14 MONTHS POST RIGHT REVERSE SHOULDER REPLACEMENT SURGERY WITH PAIN, ¿BIOPSY TAKEN AND SAMPLE GREW A BUG¿. ALL IMPLANTS REMOVED AND SPACER IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652692 EQUINOXE REVERSE 38MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R