BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13003206 · Received December 14, 2021

    Report

    Report Number
    1038671-2021-00692
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    November 18, 2021
    Report Date
    March 29, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079336
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF BOTH PATIENT-RELATED CONDITIONS AND AN INSUFFICIENT BOND BETWEEN THE HUMERAL STEM AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) HUMERAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES AND X-RAYS WERE NOT AVAILABLE FOR EVALUATION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D2B) COMMON DEVICE NAME: HUMERAL STEM PRIMARY, PRESS FIT 15MM (D4) CATALOG NUMBER: 300-01-15, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 10-JAN-2029, UNIQUE IDENTIFIER (UDI) #: (B)(4). (D11) CONCOMITANT DEVICE(S): 320-10-00, 6622588 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-15-05, 6610420 - EQ REV LOCKING SCREW. 320-20-00, 6624065 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-42-10, 6136285 - EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0. 320-20-38, 6022248 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 320-20-38, 6044687 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. 320-02-42, 6528863 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET. (G4) PMA/510(K)NUMBER: K042021. (H4) DEVICE MANUFACTURE DATE: 12-JAN-2019.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER? PENDING EVALUATION. CONCOMITANT MEDICAL DEVICE(S): 300-01-15, (B)(4) - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM; 320-10-00, (B)(4) - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; 320-15-05, (B)(4) - EQ REV LOCKING SCREW; 320-20-00, (B)(4) - EQ REVERSE TORQUE DEFINING SCREW KIT; 320-42-10, (B)(4) - EQUINOXE REVERSE 42MM HUMERAL CONST LINER +0; 320-20-38, (B)(4) - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM; 320-20-38, (B)(4) - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM.

    Description of Event or Problem · 0

    AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT WAS PREVIOUSLY REVISED ON (B)(6) 2020 FOR WITH A LOOSE HUMERAL COMPONENT FROM A SUSPECTED INFECTION. CURRENTLY, PATIENT'S STEM IS LOOSE. REMOVED HUMERAL COMPONENTS AS WELL AS GLENOSPHERE, LOCKING SCREW AND COMPRESSION SCREWS. REPLACED ALL SHOULDER COMPONENTS. THE PATIENT HAS A BMI OF 50+. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897267 EQUINOXE HUMERAL STEM PRIMARY, PRESS FIT 15MM KWT EXACTECH, INC. 320-02-42 UNK 10885862079336

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention| H