BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20732103 · Received November 20, 2024

    Report

    Report Number
    3005180920-2024-00960
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 20, 2024
    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 30 OCTOBER 2024. LOT 2100435: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAR-2021. EXPIRATION DATE: 2026-03-15. 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 REVISED. BATCH REVIEW PERFORMED ON 30 OCTOBER 2024 ON REVERSE SHOULDER SYSTEM 04.01.0170 GLENOSPHERE 39XØ24.5 (K170452) LOT. 2003971 LOT 2003971: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2021. EXPIRATION DATE: 2026-03-10. 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

    REVISION DUE TO PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. AT 3 YEARS AND 3 MONTHS POST PRIMARY THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306707 SHOULDER SYSTEM SHOULDER HUMERAL REVERSE HIGHCROSS LINER PHX MEDACTA INTERNATIONAL SA 04.01.0122 2100435 07630040706292

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention