BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21321671 · Received February 6, 2025

    Report

    Report Number
    3005180920-2025-00041
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706292
    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 16-01-2024. 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. ADDITIONAL IMPLANT INVOLVED; BATCH REVIEW PERFORMED ON 16-01-2024. REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE 39XØ24.5 (K170452) 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 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

    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. ON (B)(6) 2025, THE PATIENT REPORTED PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE AFTER LIFTING HEAVY ITEMS. THE SURGEON REVISED THE LINER, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919899 SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM PHX MEDACTA INTERNATIONAL SA 04.01.0122 2117046 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention