BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6

    MDR report key: 11371319 · Received February 24, 2021

    Report

    Report Number
    3005180920-2021-00147
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    January 29, 2021
    Report Date
    February 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802072
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 03 FEBRUARY 2021: LOT 092594: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2010. EXPIRATION DATE: 2014-11-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-JAN-2017. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: LOOKING AT THE IMAGES IT IS VISIBLE THAT THE HA COATING ON THE STEM BODY HAS BEEN COMPLETELY ABSORBED. SLIGHT SIGNS OF SCRATCHES ARE PRESENT ON THE NECK AREA. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: HIP REVISION PERFORMED 8 YEARS AND 9 MONTHS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY IN (B)(6) YEAR OLD WOMAN. 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

    REVISION SURGERY 8 YEARS AND 10 MONTHS AFTER PRIMARY FOR SUSPECTED LOOSENING. DURING THE REVISION THE STEM CAME OUT EASILY. NO INFECTION DETECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY, STEM, HEAD AND LINER REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269024 STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 01.12.026 092594 07630030802072

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention