BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-P FEMORAL STEMS

    MDR report key: 23579654 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01107
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720441
    PMA / PMN Number
    K181254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30 OCTOBER 2025. STEM: QUADRA-P 01.12.123 QUADRA-P STD. SIZE3 (K181254) LOT 2339736: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2024. EXPIRATION DATE: 18-FEB-2029. 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. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA DOUBLE MOBILITY LINER WITH A NEW ONE AND REVISED THE STEM AND HEADWITH COMPETITOR PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235268 QUADRA-P FEMORAL STEMS QUADRA-P STD. SIZE3 LZO MEDACTA INTERNATIONAL SA 01.12.123 2339736 07630040720441

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention