BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-P LAT STEM SIZE 3

    MDR report key: 19728255 · Received July 12, 2024

    Report

    Report Number
    3005180920-2024-00507
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 12, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720557
    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 20-JUN-2024: LOT 2200471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2022. EXPIRATION DATE: 2027-05-16. 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 ABOUT 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE STEM, HEAD, AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348978 QUADRA-P LAT STEM SIZE 3 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2200471 07630040720557

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention