BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22343742 · Received June 27, 2025

    Report

    Report Number
    3005180920-2025-00605
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    June 10, 2025
    Report Date
    June 26, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706308
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 JUNE 2025: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-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 EVENTS 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 DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN DUE TO A DISLOCATION OF THE MEDACTA LINER FROM THE COMPETITOR GLENOSPHERE AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. AT ABOUT 2 MONTHS FROM PRIMARY THE SURGEON REVISED THE COMPETITOR GLENOSPHERE AND MEDACTA LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845604 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM PHX MEDACTA INTERNATIONAL SA 04.01.0123 2418608 07630040706308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention