BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTA HUMERAL HEAD TALL, 50MM

    MDR report key: 23277467 · Received October 15, 2025

    Report

    Report Number
    1038671-2025-03079
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    K110706
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D1, D4, D10, G4, H4, H6. D10: 300-21-00 - 0MM FIXED ANGLED KIT: 7153537. 304-22-13 - 12.5MM PLATFORM FX STEM RIGHT: A948688. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM AN UNDERLYING PATIENT CONDITION, INFECTION, COMPONENT LOOSENING, COMPONENT SIZING, POSITIONING, OR IMPINGEMENT ISSUES, OR A COMBINATION OF THE ABOVE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, 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

    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. D10: 300-21-00 - 0MM FIXED ANGLED KIT: (B)(6), 304-22-13 - 12.5MM PLATFORM FX STEM RIGHT: (B)(6), 310-22-50 - CTA HUMERAL HEAD TALL, 50MM: (B)(6).

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 7 MONTHS AND 21 DAYS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO PAIN. THE CTA HEAD WAS CONVERTED TO A REVERSE. 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
    2648278 CTA HUMERAL HEAD TALL, 50MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization