BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK

    MDR report key: 20167737 · Received September 9, 2024

    Report

    Report Number
    3005180920-2024-00712
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802638
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 AUGUST 2024: LOT 2012687: (B)(4) MANUFACTURED AND RELEASED ON 25-FEB-2021. EXPIRATION DATE: 2026-02-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: A REVISION SURGERY WAS PERFORMED 2 YEARS AFTER THE PRIMARY IMPLANTATION OF A THA. THE REPORTED REASON FOR THE REVISION WAS ASEPTIC LOOSENING OF THE PROXIMAL STEM. THE AVAILABLE X-RAY IMAGE REVEALS RADIOLUCENCY LINES AROUND THE PROXIMAL STEM ON BOTH THE LATERAL AND MEDIAL SIDES, ALONG WITH SIGNS OF STRESS SHIELDING. ASEPTIC LOOSENING IS A KNOWN COMPLICATION DESCRIBED IN THE LITERATURE FOLLOWING PRIMARY CEMENTLESS HIP ARTHROPLASTIES, WITH CAUSES OFTEN BEING UNCLEAR. IN THIS CASE, THE EXACT CAUSE OF THE FAILURE CANNOT BE DETERMINED. INVESTIGATION PERFORMED BY MEDACTA HIP R&D PROJECT MANAGER: LOOKING AT THE IMAGES ATTACHED TO THE COMPLAINT IT IS VISIBLE THE STEM BODY COVERED WITH PATIENT BLOOD. FROM THE IMAGES IT SEEMS THAT NO HA RESIDUALS AL PRESENT ON THE STEM BODY. 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.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 2 YEARS AND 2 MONTHS POST PRIMARY DUE TO QUADRA H STEM LOOSENING. THE PATIENT WAS STABLE HOWEVER WAS EXPERIENCING THIGH AND GROIN PAIN ON WEIGHT BEARING. THE STEM AND HEAD WERE REVISED AND A COMPETITOR STEM WAS SUCCESSFULLY IMPLANTED. NO ISSUES ON THE HEAD DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538327 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK HIP STEM JDI MEDACTA INTERNATIONAL SA 2012687 07630030802638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention