BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEMS

    MDR report key: 23579959 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01125
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802041
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 NOVEMBER 2025. LOT 162211: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUNE-2016. EXPIRATION DATE: 2021-06-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS SINCE THE RELEASE. VISUAL INSPECTION: DURING THE ANALYSIS IT IS EVALUATED THAT, LOOKING AT THE STEM BODY, AN OPAQUE WHITE FILM IS VISIBLE ON A SMALL REGION OF ONE SIDE OF THE PROXIMAL PART OF THE STEM LENGTH. IT IS NOT POSSIBLE TO IDENTIFY IF THIS FILM IS HA OR BONE RESIDUAL, OR A COMBINED EFFECT. ABSORPTION OF HA FROM THE STEM BODY CAN INDICATE THAT METABOLIC ACTIVITY WAS TAKING PLACE AND THAT, PRESUMABLY, ADEQUATE BONE CONTACT WAS ACHIEVED AT THE TIME OF SURGERY. SOME SIGNS OF MINOR DAMAGE AND SCRATCHES ARE PRESENT ON THE NECK OF THE EXPLANTED STEM, WHICH IS LIKELY DUE TO THE REVISION SURGERY AND NOT RELEVANT TO THE REPORTED ISSUE. BASED ON THE ANALYSIS COMPLETED AND INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A ROOT CAUSE OF THE STEM LOOSENING REPORTED. 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 9 YEARS FROM PRIMARY REVISION SURGERY DUE TO ASEPTING STEM LOOSENING. STEM, HEAD AND LINER REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644034 QUADRA H FEMORAL STEMS QUADRA STEM STANDARD HAP 12/14 S.3 JDI MEDACTA INTERNATIONAL SA 01.12.023 162211 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention