BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H FEMORAL STEMS

    MDR report key: 23510671 · Received November 10, 2025

    Report

    Report Number
    3005180920-2025-01074
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802027
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 OCTOBER 2025, STEM: QUADRA-H 01.12.021 CEMENTLESS, HA COATED STD STEM SIZE 1 (K082792) LOT 071431: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2007. EXPIRATION DATE: JUN-2012. 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. CLINICAL EVALUATION: ALMOST 18 YEARS AFTER PRIMARY CEMENTLESS THA THE STEM STARTS TO GIVE PAIN BECAUSE PROGRESSIVE LOOSENING IS TAKING PLACE. FROM THE ONE RADIOGRAOH SUPPLIED, IT APPEARS THAT THE PROGRESSIVE LOSS OF BONE DENSITY AND LOSS OF CORTEX THICKNESS RESULTED EVENTUALLY IN STEM MOBILIZATION. THIS IS LIKELY TO HAPPEN BECAUSE THE PATIENT&SIZE39;S BONE IS LIKELY TO UNDERGO SIGNIFICANT CHANGES OVER TIME, AND THE STEM SHAPE AND DIMENSION MAY NO LONGER BE THE BEST FOR THE NEW BONE CONDITION. NO REASON TO SUSPECT A FAULTY DEVICE AS THE CAUSE OF THIS REVISION SURGERY. ROOT CAUSE:ALTHOUGH A PRECISE ROOT CAUSE CANNOT BE ESTABLISHED, IT APPEARS THAT THE PROGRESSIVE LOSS OF BONE DENSITY AND CORTICAL THICKNESS ULTIMATELY LED TO STEM MOBILIZATION. THIS IS LIKELY TO OCCUR AS THE PATIENT¿S BONE UNDERGOES SIGNIFICANT CHANGES OVER TIME. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE REVIEW OF THE DEVICE'S HISTORY DOES NOT REVEAL ANY MANUFACTURING-RELATED ISSUES.

    Description of Event or Problem · 0

    AT ABOUT 17 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TOA THIGH PAIN FOR A STEMQUADRA-H CEMENTLESSLOOSENING.DR HOCKINGS PERFORMED THIS REVISION THROUGH THE ANTERIOR APPROACH WITH NO DIFFICULTIES ANDREPLACED THE STEM WITH ANAMIS CCEMENTED STEM AND THE HEAD WITH A CERAMIC 36 M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616123 QUADRA-H FEMORAL STEMS CEMENTLESS, HA COATED STD STEM SIZE 1 JDI MEDACTA INTERNATIONAL SA 01.12.021 071431 07630030802027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention