BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE GLENOID, PEGGED BETA, LARGE

    MDR report key: 21087933 · Received January 6, 2025

    Report

    Report Number
    1038671-2025-00105
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    August 21, 2022
    Report Date
    June 24, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862084521
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 300-01-15 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM: 7160491, 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA): 7169429, 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S: 6882731. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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

    THE REVISION REPORTED MAY BE THE RESULT OF THE GLENOID LOOSENING AS REPORTED. HOWEVER, THE LOOSENING CANNOT BE CONFIRMED AND ANY POTENTIAL CONTRIBUTIONS FROM USER OR PATIENT-RELATED CONTRIBUTING FACTORS TO THE EVENT CANNOT BE EVALUATED AS NO RADIOGRAPH, IMAGES, OR CLINICAL INFORMATION WAS PROVIDED. THE REASON FOR THE INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. A REVIEW OF THE STERILE CERTIFICATE WAS PERFORMED AND THE STERILE LOT WAS ACCEPTED TO THE REQUIREMENTS. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    APPROXIMATELY 6 MONTH(S) AND 26 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED SEPTIC LOOSENING WITH SEVERE PAIN. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION FOR THE LOOSENING WITH THE REPORTED REMOVAL OF THE GLENOID COMPONENT. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381551 EQUINOXE GLENOID, PEGGED BETA, LARGE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862084521

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization SEE H11