BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 22058685 · Received May 21, 2025

    Report

    Report Number
    3005180920-2025-00439
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 20, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040733977
    PMA / PMN Number
    K192967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 APRIL 2025: LOT 2012561: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAR-2021. EXPIRATION DATE: 2026-02-18. 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

    THE PATIENT HAD PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. AT ABOUT 2 MONTHS FROM PRIMARY THE SURGEON REVISED THE DIAPHYSIS, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645052 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM LONG HUMERAL DIAPHYSIS - L160 - 11 KWS MEDACTA INTERNATIONAL SA 04.01.0218 2012561 07630040733977

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention