BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA S FEMORAL STEMS

    MDR report key: 22726218 · Received August 6, 2025

    Report

    Report Number
    3005180920-2025-00709
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 14, 2025
    Report Date
    August 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030801860
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 JULY 2025. LOT 083654: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2009. EXPIRATION DATE: 2013-12-31. 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. 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 16 YEARS 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 MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365530 QUADRA S FEMORAL STEMS CEMENTLESS, SAND BLASTED STD STEM SIZE 5 JDI MEDACTA INTERNATIONAL SA 01.12.005 083654 07630030801860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention