BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER - TINBN COATING

    MDR report key: 22662919 · Received July 30, 2025

    Report

    Report Number
    3005180920-2025-00726
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 30, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630345708915
    PMA / PMN Number
    K203755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22-07-2025: REVERSE SHOULDER SYSTEM 04.01.0269 SENSITIN GLENOSPHERE 36XØ24.5 (K203755) LOT 2404992: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-09-2024 EXPIRATION DATE: 2029-08-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED HUMERUS. THE SURGEON REVISED THE LINER, GLENOSPHERE, DIAPHYSIS, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT (B)(4) WAS FILED. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA GLENOSPHERE AND COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55641 SHOULDER - TINBN COATING REVERSE SHOULDER SYSTEM SENSITIN GLENOSPHERE 36XØ24.5 KWS MEDACTA INTERNATIONAL SA 04.01.0269 2404992 07630345708915

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention