BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 21771297 · Received April 4, 2025

    Report

    Report Number
    3005180920-2025-00288
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706179
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 MARCH 2025. LOT 2404997: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29/07/2024. EXPIRATION DATE: 01/07/2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT REVISED. BATCH REVIEW PERFORMED ON 25 MARCH 2025 ON REVERSE SHOULDER SYSTEM 04.01.0122 HUMERAL REVERSE HC LINER Ø39/+0MM (K170452) LOT. 2405698. LOT 2405698: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28/05/2024. EXPIRATION DATE: 08/05/2029. 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 CAME IN REPORTING LOOSENESS IN THE SHOULDER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND LINER. THE PATIENT'S SHOULDER WAS LOOSE, NOT THE IMPLANTS. THE SURGEON PUT IN A THICKER POLY, BUT IT WASN'T ENOUGH; IT WAS STILL LOOSE, SO HE PUT IN A THICKER METAPHYSIS TO BUILD IT UP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323321 SHOULDER SYSTEM REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0° PHX MEDACTA INTERNATIONAL SA 04.01.0110 2404997 07630040706179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention