BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ REV LOCKING SCREW

    MDR report key: 19728721 · Received July 12, 2024

    Report

    Report Number
    1038671-2024-02371
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 20, 2024
    Report Date
    October 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086495
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: (B)(6), 300-30-11 - EQUINOXE PRESERVE STEM 11MM. (B)(6), 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. (B)(6), 320-15-05 - EQ REV LOCKING SCREW. (B)(6), 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. (B)(6), 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. (B)(6), 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. (B)(6), 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. (B)(6), 320-35-01 - SMALL GLENOID PLATE. (B)(6), 320-40-00 - 145-DEG PE 40MM HUM LINER +0. (B)(6), 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT. (B)(6), 321-52-10 - 3.2MM K-WIRE, THD, SHORT 2 K-WIRES PER PACK.

    Additional Manufacturer Narrative · 0

    *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) BRAND NAME: EQ REV LOCKING SCREW, PRODUCT CODE: KWT, COMMON DEVICE NAME: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED, CATALOG NUMBER: 320-15-05, EXPIRATION DATE: 30-JUL-2028, SERIAL NUMBER: (B)(6), UNIQUE IDENTIFIER (UDI) #: (B)(4). (H4( DEVICE MANUFACTURE DATE: 02-AUG-2023. (H6) MEDICAL DEVICE PROBLEM CODE: 2907 - DETACHMENT OF DEVICE OR DEVICE COMPONENT.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 10 MONTHS AFTER INITIAL RIGHT TSA, THE PATIENT WAS REVISED AFTER FEELING PAIN WHILE DOING HANDY WORK. THE GLENOSPHERE WAS LOOSE AND WAS REPLACED ALONG WITH A NEW POLY LINER AND SCREW. THE EVENT IS RELATED TO THE BREAKAGE OF A DEVICE. ALL PIECES THAT FELL INTO THE WOUND SITE WERE REMOVED. THE EVENT DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385496 EQ REV LOCKING SCREW PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086495
    2485918 EQ REV LOCKING SCREW PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086495

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11.