BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEMS

    MDR report key: 20450295 · Received October 15, 2024

    Report

    Report Number
    3005180920-2024-00836
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 15, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 SEPT 2024: LOT 162967: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2016. EXPIRATION DATE: 2021-06-22. 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.

    Description of Event or Problem · 0

    AT 7 YEARS AND 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISTALLY POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319553 QUADRA H FEMORAL STEMS HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.22SN 162967

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention