BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA P FEMORAL STEMS

    MDR report key: 25148936 · Received May 12, 2026

    Report

    Report Number
    3005180920-2026-00403
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 12, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971243422
    PMA / PMN Number
    K192827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 APRIL 2026: LOT: 1910214: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2020. EXPIRATION DATE: 2025-APR-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. DEVICES OF THE SAME BATCH BUT RESTERILIZED HAVE BEEN CONSIDERED. 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

    THE PATIENT HAD PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO REPORTS OF TRAUMA OR BONE QUALITY ISSUES. AT ABOUT 3 YEARS FROM THE PRIMARY SURGERY, THE SURGEON REVISED THE D 28/DMF LINER TO A SAME SIZE LINER, AND THE 28MM BIOLOX HEAD S TO A 28MM BIOLOX OPTION HEAD WITH XL OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174145 QUADRA P FEMORAL STEMS QUADRA-P SHORT NECK STD STEM SIZE1 LZO MEDACTA INTERNATIONAL SA 01.12.251 1910214 07630971243422

    Patients

    Seq Age Sex Outcome Treatment
    1