BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21167796 · Received January 16, 2025

    Report

    Report Number
    3005180920-2024-01149
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 20, 2024
    Report Date
    January 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706575
    PMA / PMN Number
    K170452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23-12-2024 LOT 1910953: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-06-2020. EXPIRATION DATE: 2025-05-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 2 OTHER SIMILAR REPORTED EVENTS. ADDITIONAL ITEM INVOLVED IN THE EVENT; BATCH REVIEW PERFORMED ON 23-12-2024. REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT. 2117046 LOT 2117046: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-01-2022. EXPIRATION DATE: 2027-01-02. 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. 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

    ON (B)(6) 2018 THE PATIENT HAD A PRIMARY ANATOMIC SHOULDER SURGERY. ON (B)(6) 2024, THE SURGEON CONVERTED THE PATIENT FROM AN ANATOMICAL SHOULDER TO A REVERSE SHOULDER DUE TO THE PATIENT REPORTING PAIN RELATED TO A ROTATOR CUFF FAILURE. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE GLENOSPHERE FROM THE LINER. THE SURGEON CLOSED REDUCED UNDER ANESTHESIA THE PATIENT AND NO IMPLANTS WERE REVISED. THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509295 SHOULDER SYSTEM GLENOSPHERE 39XØ24.5 PHX MEDACTA INTERNATIONAL SA 04.01.0170 1910953 07630040706575

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other