BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9896985 · Received March 30, 2020

    Report

    Report Number
    3005180920-2020-00203
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 30, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802041
    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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 13 MARCH 2020: LOT 163265: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEP-2016. EXPIRATION DATE: 2021-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR EVENT REPORTED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: PARTIAL HIP REVISION SURGERY (STEM AND HEAD) PERFORMED 3 YEARS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD FARMER. RADIOLOGICAL IMAGES PROVIDED SHOW THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONES 1, 2, 6 AND 7 AND SIGNS OF STRESS SHIELDING SUGGESTING STEM MOBILIZATION. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY AND CAUSES ARE OFTEN UNKNOWN. EARLY RETURN TO HIGH LEVEL OF ACTIVITIES MAY REDUCE PRIMARY STABILITY OF THE STEM AND HINDER IMPLANT FIXATION. NO CONCLUSION CAN BE DRAWN ON THE BASIS OF AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 3 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY DUE TO THE PROXIMAL LOOSENING OF A QUADRA H STEM. THE SURGEON REVISED THE STEM AND BALL HEAD. THE PATIENT WAS A HEAVY WORKING FARMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359797 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.023 163265 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention