BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 11576407 · Received March 26, 2021

    Report

    Report Number
    1038671-2021-00132
    Event Type
    Injury
    Date Received
    March 26, 2021
    Date of Event
    March 2, 2021
    Report Date
    May 12, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086419
    PMA / PMN Number
    K110708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF POOR BONE QUALITY AND AN INSUFFICIENT BOND BETWEEN THE GLENOID BASEPLATE AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) GLENOID LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D2) COMMON DEVICE NAME: RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT (D4) CATALOG NUMBER: 320-15-04, SERIAL NUMBER: (B)(6) EXPIRATION DATE: 21-APR-2029, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G4) PMA/510(K)NUMBER: K110708 (H4) DEVICE MANUFACTURE DATE: 22-APR-2019 (D10) CONCOMITANT DEVICES: 320-10-00, 6159881 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 320-38-00, 6054852 - EQUINOXE REVERSE 38MM HUMERAL LINER +0 320-02-38, 5372918 - RS EXP GLENOSPHERE 38M M+4 320-20-00, 6136875 - RS TORQUE SCREW KIT 320-20-22, 4519568 - 22MM COMPRESSION SCREW 320-15-05, 6152600 - EQ REV LOCKING SCREW 320-20-22, 5494681 - 22MM COMPRESSION SCREW 320-20-26, 5901911 - 26MM COMPRESSION SCREW 320-20-26, 6104386 - 26MM COMPRESSION SCREW 320-20-30, 5961269 - 30MM COMPRESSION SCREW TPA-13, AB4152 - XS CEMENT RESTRICTOR

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE(S): 320-02-38, 5372918 - RS EXP GLENOSPHERE 38M M+4. 320-10-00, 6159881 - RS ADAPTER TRAY. 320-15-04, 5976414 - RS GLENOID PLT 8 DEG RIGHT POST AUG. 320-20-00, 6136875 - RS TORQUE SCREW KIT. 320-20-22, 4519568 - 22MM COMPRESSION SCREW. 320-15-05, 6152600 - EQ REV LOCKING SCREW. 320-20-22, 5494681 - 22MM COMPRESSION SCREW. 320-20-26, 5901911 - 26MM COMPRESSION SCREW. 320-20-26, 6104386 - 26MM COMPRESSION SCREW. 320-20-30, 5961269 - 30MM COMPRESSION SCREW. TPA-13, AB4152 - XS CEMENT RESTRICTOR.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 26 MONTHS AFTER THE INITIAL R TSA, THE (B)(6) Y/O FEMALE PATIENT WAS EXPERIENCING PAIN IN THE REVISED RIGHT REVERSE SHOULDER. HER BONE QUALITY WAS DETERMINED TO BE VERY BAD AT A PRIOR REVISION. X-RAYS SHOWED A LOOSE BASEPLATE. GIVEN HEALTH OF PATIENT, SURGEON CHOSE TO REPLACE THE REVERSE SHOULDER FOR A "BIG BALL HEMI" TO RELIEVE PAIN AND ALLOW FOR SOME FUNCTION. EXPLANTS WILL NOT BE RETURNED PER HOSPITAL. PATIENT IS EXPECTED TO RECOVER WELL AND LEFT THE OR STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471293 EQUINOXE RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT KWT EXACTECH, INC. 320-10-00 UNK 10885862086419

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R