BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    MDR report key: 20340598 · Received September 30, 2024

    Report

    Report Number
    1038671-2024-03759
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    September 16, 2024
    Report Date
    December 19, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D8. G4: 510K IS UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED H6. THE FOLLOWING SECTIONS WERE CORRECTED: B2. THE REASON FOR THE REVISION REPORTED WAS LIKELY DUE TO A FAILED ROTATOR CUFF. THE CAUSE OF THE ROTATOR CUFF FAILURE CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION OR RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 314-02-33 - UHMWPE POST AUG GLENIOD MEDIUM, RIGHT 6584615. 310-61-50 - STEMLESS HUMERAL HEAD 50MM X 19MM X BETA A229780. 319-01-32 - STEINMANN PIN STERILE 3.2MM X 178MM A479767. 300-62-03 - STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 3 A696703. 315-35-00 - GLND KWIRE A821162.

    Description of Event or Problem · 0

    AS REPORTED, A PATIENT UNDERWENT A REVISION AND WAS CONVERTED FROM A STEMLESS ANATOMIC TOTAL SHOULDER ARTHROPLASTY TO A REVERSE TOTAL SHOULDER ARTHROPLASTY DUE TO CUFF FAILURE. NO ISSUES DURING THE REVISION. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2006599 EQUINOXE PRIMARY SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11.