BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1

    MDR report key: 14303478 · Received May 6, 2022

    Report

    Report Number
    3005180920-2022-00328
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 6, 2022
    Report Date
    May 5, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802027
    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 06 APRIL 2022: LOT 152958: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-OCT-2015. EXPIRATION DATE: 2020-09-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL DIRECTOR: ABOUT 7 YEARS AFTER PRIMARY CEMENTLESS THA IN AN ELDERLY LADY, EXTENSIVE RADIOLUCENT LINES ARE VISIBLE ON THE RADIOGRPHIC CONTROL AROUND THE STEM. IN ABSENCE OF A SILENT INFECTION, THIS IS PROBABLY A CASE OF ASEPTIC LOOSENING, A POSSIBLE ADVERSE EVENT FOLLOWING THA, DESCRIBED IN LITERATURE. CAUSES REMAIN OFTEN UNDETERMINED. WE SEE NO DISCERNIBLE CLUES THAT COULD POINT TO A SPECIFIC CAUSE FOR THIS ADVERSE EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY FOLLOWING STEM LOOSENING 6 YEARS AND 5 MONTHS AFTER PRIMARY. THE STEM, LINER, AND HEAD WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205093 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.021 152958 07630030802027

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention