BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22991529 · Received September 8, 2025

    Report

    Report Number
    3005180920-2025-00885
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 19, 2025
    Report Date
    September 8, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706087
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 SEPT 2025. LOT 1902898A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-08-2024. EXPIRATION DATE: 24-07-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, TWO ITEMS FROM THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR REPORTED EVENT DURING THE REVIEW PERIOD. CONCLUSION: 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

    14 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED PAIN DUE TO A SUBSIDED STEM OF UNKNOWN CAUSE. THE SURGEON REVISED THE METAPHYSIS AND LINER, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168700 SHOULDER SYSTEM STANDARD HUMERAL DIAPHYSIS - CEMENTLESS - 14 PHX MEDACTA INTERNATIONAL SA 04.01.0009 1902898A 07630040706087

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention