BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø40

    MDR report key: 15542035 · Received October 5, 2022

    Report

    Report Number
    3005180920-2022-00749
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    September 12, 2022
    Report Date
    October 5, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040713139
    PMA / PMN Number
    K170910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 SEPTEMBER 2022: LOT 2004011: 12 ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2021. EXPIRATION DATE: 2026-02-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. SINCE RELEASE TO DATE, 5 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE SURGEON OPERATED AGAIN THE PATIENT TO CHANGE THE HEAD ORIENTATION IN AN ANATOMICAL HEMI PROSTHESIS SHOULDER. HEAD AND DOUBLE ECCENTER REVISED SUCCESSFULLY. A HEAD OF THE SAME SIZE WAS IMPLANTED BUT WITH A DIFFERENT ORIENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2598903 ANATOMICAL SHOULDER SYSTEM METAL HUMERAL HEAD Ø40 SHOULDER METAL HUMERAL HEAD KWS MEDACTA INTERNATIONAL SA 04.01.0090 2004011 07630040713139

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention