BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHOULDER SYSTEM

    MDR report key: 20426057 · Received October 11, 2024

    Report

    Report Number
    3005180920-2024-00823
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706315
    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 23 SEPT 2024. LOT 2347108: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-FEBR-2024. EXPIRATION DATE: 2029-02-17. 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.

    Description of Event or Problem · 0

    AT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312658 SHOULDER SYSTEM SHOULDER LINER PHX MEDACTA INTERNATIONAL SA 04.01.0124 2347108 07630040706315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention