BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21411258 · Received February 19, 2025

    Report

    Report Number
    3005180920-2025-00097
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    January 31, 2025
    Report Date
    February 19, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03-02-2025 LOT 2415052: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-07-2024. EXPIRATION DATE: 2029-07-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT REVISED. BATCH REVIEW PERFORMED ON 03-02-2025 ON REVERSE SHOULDER SYSTEM 04.01.0170. GLENOSPHERE - Ø39X24.5 (K170452) LOT. 2414218. LOT 2414218: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-09-2024. EXPIRATION DATE: 2029-09-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 1 WEEK FROM PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, LINER, METAPHYSIS, AND DIAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42430 SHOULDER SYSTEM SHOULDER HUMERAL REVERSE HC LINER PHX MEDACTA INTERNATIONAL SA 04.01.0123 2415052 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention