BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1

    MDR report key: 12159065 · Received July 13, 2021

    Report

    Report Number
    3005180920-2021-00585
    Event Type
    Injury
    Date Received
    July 13, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802133
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02.07.2021: LOT 150990: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-AUG-2015. EXPIRATION DATE: 30-06-2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER REPORTED EVENT SINCE 2017. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: FEMORAL COMPONENT REVISION PERFORMED 5 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN (B)(6) YEAR OLD MAN. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED, RADIOLUCENT LINES AND SIGNS OF STRESS SHIELDING ARE VISIBLE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    5 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON PERFORMED A REVISION DUE TO A MOBILIZED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060599 STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1 CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.031 150990 07630030802133

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention