BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED, RIGHT, 16 POST AUG UHMWPE GLENOID

    MDR report key: 20978501 · Received December 19, 2024

    Report

    Report Number
    1038671-2024-04957
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    K121220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PAIN REPORTED MAY BE THE RESULT OF THE GLENOID LOOSENING AS REPORTED. HOWEVER, THE FAILURE CANNOT BE CONFIRMED AS NO RELEVANT CLINICAL INFORMATION, IMAGES, OR RADIOGRAPHS WERE PROVIDED. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, PATIENT, OR USER-RELATED ISSUES TO THE EVENT CANNOT BE DETERMINED FROM THE REPORTED INFORMATION. D1: CORRECTED. H6: CORRECTED COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: 2974354, 310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA): 2946816. 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.

    Description of Event or Problem · 0

    APPROXIMATELY 10 YEAR(S), 8 MONTH(S) AND 1 DAY(S) POST-OPERATIVE OF AN INITIAL RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. PATIENT REPORTS GRADUAL INCREASE IN PAIN OVER LAST 2 YEARS, GLENOID LOOSENING WITH SEVERE GLENOID BONE LOSS. THE PATIENT UNDERWENT A STANDARD TOTAL REVISION, WITH THE REPORTED REMOVAL OF THE REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, AND GLENOID COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023428 MED, RIGHT, 16 POST AUG UHMWPE GLENOID PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization SEE H11.