BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 16668662 · Received April 3, 2023

    Report

    Report Number
    1038671-2023-00574
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    March 2, 2023
    Report Date
    November 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086617
    PMA / PMN Number
    K093275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: A101117, 308-01-09 - 9X80MM DISTAL STEM MODULAR CEMENTED. 6577441, 308-05-22 - DISTAL FIXATION RING HA 22.5. 7117065, 308-08-00 - XS PROX BODY +0. A111536, 308-15-01 - TAPER LOCKING SCREW 0. A369316, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. A369830, 320-15-05 - EQ REV LOCKING SCREW. A367023, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S407866, 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. A209792, 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S383999, 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. S384027, 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. A295953, 320-31-36 - GLENOSPHERE, 36MM. 6149570, 320-35-07 - SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT. A368531, 531-78-20 - SHOULDR GPS HEX PINS KIT. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED DISLOCATION AND REVISION ARE RELATED TO ANY DESIGN, MANUFACTURING, OR PATIENT RELATED ISSUES. THE CAUSE OF THE REVISION IS MOST LIKELY IS RELATED TO THE PATIENT¿S UNDERLYING CONDITION; HOWEVER, THAT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 70 YO FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE PATIENT DISLOCATED REACHING DOWN FOR SOMETHING. THE POLY WAS REPLACED. THERE WERE NO SURGICAL DELAYS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ANTICIPATED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265835 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 36MM HUMERAL LINER +0 UNCONSTRAINED UNK 10885862086617

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| R SEE H10