BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3

    MDR report key: 16032296 · Received December 22, 2022

    Report

    Report Number
    3005180920-2022-00957
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    December 9, 2022
    Report Date
    December 22, 2022
    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 · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2022 LOT 071435: 45 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2007. EXPIRATION DATE: (B)(6) 2012. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 41 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: REVISION PERFORMED 14 YEARS AND 6 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN 83 YEAR OLD MAN. NO INFORMATION CONCERNING PATIENT GENERAL HEALTH STATUS AND THE PRESENCE OF COMORBIDITIES IS AVAILABLE. IN THE RADIOGRAPHIC IMAGE PROVIDED, RADIOLUCENT LINES 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. PRELIMINARY INVESTIGATION PERFORMED BY R&D MANAGER: LOOKING AT THE IMAGES ATTACHED TO THE COMPLAINT IT ONLY THE PROXIMAL PART OF THE BODY AND NECK BOTH ANTERIOR AND POSTERIOR ARE VISIBLE. THE STEM IS COVERED BY PATIENT BLOOD BUT IS SEEMS THAT NO HA RESIDUALS ARE PRESENT, ADDITIONALLY SOME SIGNS AND SCRATCHES ARE VISIBLE ON THE NECK PART PROBABLY DUE TO REVISION SURGERY. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF REPORTED COMPLAINT.

    Description of Event or Problem · 0

    AT ABOUT 14 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY BY REVISING STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2917948 STEM: QUADRA-H 01.12.023 CEMENTLESS, HA COATED STD STEM SIZE 3 HIP CEMENTLESS, HA COATED STD STEM JDI MEDACTA INTERNATIONAL SA 01.12.023 071435 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention