BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA P FEMORAL STEMS

    MDR report key: 18011655 · Received October 26, 2023

    Report

    Report Number
    3005180920-2023-00832
    Event Type
    Injury
    Date Received
    October 26, 2023
    Date of Event
    October 4, 2023
    Report Date
    October 3, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040732086
    PMA / PMN Number
    K192827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY ON 26 SEP 2024, FDA COMMUNICATED DISCREPANCIES RELATED TO EMDR REPORTS, REVIEWING THE DISCREPANCIES SOME FOLLOW-UPS HAVE BEEN DONE. THE CORRECT BRAND NAME WAS ENTERED (SECTION D1) ACCORDING TO THE GUDID DATABASE. THE K-NUMBER IN THE SECTION G4 WAS UPDATED: K192827.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 OCTOBER 2023. LOT 2107725: 17 ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2021. EXPIRATION DATE: 2026-10-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 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 ABOUT 1 YEAR AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000280 QUADRA P FEMORAL STEMS HIP STEM CEMENTED LZO MEDACTA INTERNATIONAL SA 2107725 07630040732086

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention