BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-P LAT STEM SIZE 1

    MDR report key: 19814522 · Received July 24, 2024

    Report

    Report Number
    3005180920-2024-00545
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 24, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720533
    PMA / PMN Number
    K181254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 JULY 2024: LOT 2200469: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2022. EXPIRATION DATE: 2027-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 8 MONTHS AFTER 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, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302162 QUADRA-P LAT STEM SIZE 1 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2200469 07630040720533

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention