BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4

    MDR report key: 17105639 · Received June 12, 2023

    Report

    Report Number
    3005180920-2023-00414
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802164
    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 17 MAY 2023: LOT 150213: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: REVISION ABOUT 7 YEARS 5 MONTHS AFTER THE PRIMARY TOTAL HIP SURGERY DUE TO ASEPTING STEM LOOSENING IN A 73 YEAR OLD PATIENT. THE SURGEON REVISED SUCCESSFULLY STEM, HEAD AND LINER. FROM THE RADIOGRAPHIC IMAGE 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 · 0

    AT ABOUT 7 YEARS 5 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO ASEPTING STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1763177 QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 4 HIP CEMENTLESS STEM JDI MEDACTA INTERNATIONAL SA 01.12.034 150213 07630030802164

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention