BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 25148960 · Received May 12, 2026

    Report

    Report Number
    3005180920-2026-00408
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSD
    UDI-DI
    07630040728065
    PMA / PMN Number
    K193175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 APRIL 2026 REVERSE SHOULDER SYSTEM 04.01.0207 LAT. GLENOSPHERE 36XD 24.5 (K193175) LOT 2501778: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APRIL-2025. EXPIRATION DATE: 2030-04-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM.TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. REVERSE SHOULDER SYSTEM 04.01.0120 HUMERAL REVERSE HC LINER D 36/+3MM (K170452) LOT 2314161: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEP-2023. EXPIRATION DATE: 2028-08-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON CONFIRMED NO GLENOID FRACTURE WAS PRESENT. THE SURGEON REVISED THE METAPHYSIS, GLENOSPHERE AND THE LINER D 36/+3MM TO A CONSTRAINED E-CROSS LINER D 39/+0. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174151 SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5 HSD MEDACTA INTERNATIONAL SA 04.01.0207 2501778 07630040728065

    Patients

    Seq Age Sex Outcome Treatment
    1