BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENT

    MDR report key: 16888849 · Received May 8, 2023

    Report

    Report Number
    1038671-2023-00930
    Event Type
    Injury
    Date Received
    May 8, 2023
    Date of Event
    March 22, 2023
    Report Date
    December 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086709
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 7304326 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM A091873 315-35-00 - GLND KWIRE 6917199 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE A127824 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A055509 320-15-01 - EQ REV GLENOID PLATE A085158 320-15-05 - EQ REV LOCKING SCREW A051973 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT S365062 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM A068509 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM A118375 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S345990 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM A116183 531-78-20 - SHOULDR GPS HEX PINS KIT A116189 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 EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES, FINISHED PRODUCT RELEASE WAS REVIEWED. THE CAUSE OF SURGICAL REVISION CANNOT BE CONCLUSIVELY DETERMINED, CLINICAL INFORMATION WAS NOT PROVIDED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION - DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. IT WAS STATED THAT THE PATIENT INFECTION WAS NOT RELATED TO THE IMPLANTS BY THE REPORTER OF THE EVENT. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6), 2022, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2023. THE PATIENT PRESENTED WITH INFECTION. NOT RELATED TO EXACTECH¿S IMPLANTS. THE POLY WAS REVISED FOR INFECTION PREVENTION. THERE WAS NO WEAR TO THE IMPLANT NOTICED. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT AVAILABLE FOR RETURN. REASON WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727040 EQUINOXE PRIMARY SHOULDER COMPONENT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +2.5 UNK 10885862086709

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention