BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 15938904 · Received December 8, 2022

    Report

    Report Number
    1038671-2022-01581
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    November 22, 2022
    Report Date
    March 30, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 SURGICAL REVISION FOR INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. CONCOMITANT DEVICE(S): 4212660, 304-22-13 - 12.5MM PLATFORM FX STEM RIGHT; 6417954, 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE; 6821607, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; 6782821, 320-15-01 - EQ REV GLENOID PLATE; 6867863, 320-15-05 - EQ REV LOCKING SCREW; 6803441, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT; S108285, 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; S107943, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; S217762, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; S125272, 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; S055120, 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM; 6792310, 531-20-00 - SHLDR GPS RVRS DRILL KIT; 6873955, 531-78-20 - SHOULDR GPS HEX PINS KIT; 1000321247, A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, D1, D4, D8, G4, H2, H4, H6 HEALTH EFFECT - CLINICAL CODE, INVESTIGATION FINDINGS AND H11. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT HAD A REVISION ON THE RIGHT SHOULDER FOR AN INFECTION. THERE WERE NO NOTED ISSUES DURING THE REVISION SURGERY. THE PATIENT WAS LAST KNOWN TO BE INSTABLE CONDITION. THE DEVICE WILL NOT BE RETURNED, "IMPLANTS REQUIRED FOR COLLECTION OF INFECTED MATERIALS ¿ SENT TO HOSPITAL PATHOLOGY". NO OTHER PATIENT INFORMATION IS KNOWN. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373898 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10.