BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1

    MDR report key: 8105807 · Received November 27, 2018

    Report

    Report Number
    3005180920-2018-00951
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 30, 2018
    Report Date
    November 27, 2018
    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 · 1

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON NOVEMBER 16, 2018; FEMORAL COMPONENT REVISION OCCURRED 9 MONTHS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR-OLD OBESE WOMAN. FEMORAL STEM LOOKS SLIGHTLY UNDERSIZED AND REASONS FOR THIS CHOICE CANNOT BE ASSESSED NOT HAVING A PREOPERATIVE X-RAY IMAGE: PATIENT ANATOMY AND BONE MORPHOLOGICAL CHARACTERISTICS MAY BE ONE CAUSE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE. BATCH REVIEW PERFORMED ON 27 NOVEMBER 2018; LOT 161546: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01 JUNE 2016 . EXPIRATION DATE: 2021-05-29; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO STEM LOOSENING 10 MONTHS AFTER THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945721 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 161546 07630030802027

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention