BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA P FEMORAL STEMS

    MDR report key: 21695440 · Received March 26, 2025

    Report

    Report Number
    3005180920-2025-00202
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    February 28, 2025
    Report Date
    March 26, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971243422
    PMA / PMN Number
    K192827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: A FEW DAYS AFTER THE IMPLANTATION OF A TOTAL HIP ARTHROPLASTY, THE PATIENT PRESENTED WITH A PERIPROSTHETIC FRACTURE REQUIRING REVISION SURGERY. NO TRAUMA WAS REPORTED; THE PATIENT ONLY COMPLAINED OF PAIN. THE AVAILABLE X-RAYS CLEARLY SHOW A PROXIMAL PERIPROSTHETIC FRACTURE INVOLVING THE LESSER TROCHANTER. DETERMINING THE EXACT ROOT CAUSE IS CHALLENGING WITH THE CURRENT INFORMATION. HOWEVER, IN THE IMMEDIATE POST-OPERATIVE PERIOD, THE BONE MAY BE WEAKENED DUE TO NORMAL FEMORAL PREPARATION. ADDITIONALLY, THE BONE QUALITY OF THIS 83-YEAR-OLD PATIENT IS REPORTED TO BE POOR. IN THIS CONDITION, EVEN A SUDDEN/INADVERTENT MOVEMENT MAY HAVE LED TO THE EARLY FRACTURE. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A DEVICE-RELATED ISSUE. BATCH REVIEW PERFORMED ON 03-MAR-2025: LOT 1910214: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2020. EXPIRATION DATE: 14-APR-2025. 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. 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 2 WEEKS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC BONE FRACTURE. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132727 QUADRA P FEMORAL STEMS QUADRA-P SHORT NECK STD STEM SIZE 1 LZO MEDACTA INTERNATIONAL SA 01.12.251 1910214 07630971243422

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention