BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2

    MDR report key: 19749802 · Received July 16, 2024

    Report

    Report Number
    3005180920-2024-00511
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802034
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 JUNE 2024: LOT 160081: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-APR-2016. EXPIRATION DATE: 2021-04-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: A REVISION SURGERY WAS PERFORMED ABOUT 8 YEARS AFTER THE PRIMARY IMPLANT OF A THA (RIGHT SIDE). THE PATIENT COMPLAINED OF PAIN AND THE REPORTED REASON WAS ASEPTIC LOOSENING OF THE STEM. THE AVAILABLE X-RAYS CONFIRM THE LOOSENING OF THE STEM WITH RADIOLUCENCY LINES ON BOTH THE MEDIAL AND LATERAL SIDES. ADDITIONALLY, DISTAL CORTICAL THICKENING IS EVIDENT, WHICH, IN CONJUNCTION WITH LOCAL DEMINERALIZATION OF THE GREATER TROCHANTER, INDICATES A CONDITION OF STRESS SHIELDING. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE EXACT REASON FOR THIS FAILURE CANNOT BE DETERMINED. INVESTIGATION PERFORMED BY MEDACTA R&D HIP PROJECT MANAGER: LOOKING AT THE IMAGES ATTACHED TO THE COMPLAINT IT IS VISIBLE THE EXPLANTED STEM COVERED WITH PATIENT BLOOD. THE STEM IS WRAPPED IN A GAUZE AND ONLY PROXIMAL PART IS VISIBLE. SOME SCRATCHES ARE PRESENT ON THE NECK PART PROBABLY DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DEFINE THE ROOT CAUSE OF REPORTED COMPLAINT.

    Description of Event or Problem · 0

    AT ABOUT 7 YEARS 11 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO ASEPTIC STEM LOOSENING (RIGHT SIDE). ALL COMPONENTS WERE SUCCESSFULLY REVISED. QUADRA-H WAS REVISED WITH QUADRA-R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714752 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 160081 07630030802034

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention