BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEMS

    MDR report key: 23886575 · Received December 24, 2025

    Report

    Report Number
    3005180920-2025-01283
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    December 15, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802058
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 DECEMBER 2025: LOT: 153554: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2015. EXPIRATION DATE: 2020-OCT-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INVESTIGATION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGER: FROM THE IMAGE AND THE INFORMATION PROVIDED IT IS VISIBLE THE EXPLANTED STEM IS COVERED WITH PATIENT BLOOD RESIDUALS. IT SEEMS THAT NOT HA COATING REMAINS ON THE STEM BODY, MEANING THAT THE STEM WAS CORRECTLY IN CONTACT WITH THE PATIENT & SIZE 39 BONE DURING THE FIRST YEARS OF IMPLANTATION. UNFORTUNATELY, ONLY ONE SIDE OF THE STEM IS VISIBLE AND FOR THIS REASON, IT IS NOT POSSIBLE TO COMPLETE THE ANALYSIS. THE ROOT CAUSE OF THE STEM LOOSENING REMAINS UNKNOWN. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: 10 YEARS AFTER PRIMARY CEMENTLESS THA AN INFECTION OCCURS AND THE FEMORAL STEM GETS LOOSE. THE DEVICES WERE APPARENTLY VERY WELL IMPLANTED AND THEY MUST HAVE SERVED PROPERLY FOR 10 YEARS. SECONDARY INFECTIONS ARE A POSSIBLE ADVERSE EVENT; THEY NORMALLY DO NOT ORIGINATE FROM THE DEVICE AREA BUT CAN LOCALIZE OVER THE IMPLANT AND CREATE LOOSENING. THE IMPLANTED DEVICES ARE NOT RESPONSIBLE FOR THE ONSERT OF THIS COMPLICATION. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD HIP PAIN AND INFECTION. THE X-RAY SUGGESTED SEPTIC LOOSENING OF THE STEM. AT ABOUT 9 YEARS AND 11 MONTHS POST PRIMARY REVISION PERFORMED AND THE STEM WAS REMOVED WITH VERY MINIMAL EFFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2057941 QUADRA H FEMORAL STEMS QUADRA STEM STANDARD HAP 12/14 S.4 JDI MEDACTA INTERNATIONAL SA 01.12.024 153554 07630030802058

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention