BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM SIZE 5 LAT

    MDR report key: 6847620 · Received September 7, 2017

    Report

    Report Number
    3005180920-2017-00498
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 8, 2017
    Report Date
    September 7, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802171
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: HIP REVISION SURGERY OCCURRED 5 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. THE PATIENT WAS COMPLAINING ABOUT PAIN. THE SINGLE RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF RADIOLUCENT LINES IN GRUEN ZONES 1 AND 7 THAT ARE SUGGESTIVE OF IMPLANT ASEPTIC MOBILIZATION. THE STEM LOOKS SLIGHTLY UNDERSIZED AND IN VARUS POSITION. THIS COULD BE DUE TO A PARTICULAR PATIENT ANATOMY THAT CANNOT BE ASSESSED ON THE BASIS OF THE SINGLE ANTERO-POSTERIOR X-RAY AVAILABLE. ASEPTIC LOOSENING IS A POSSIBLE, LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS THA AND CAUSES ARE OFTEN UNKNOWN. THE REASON OF THIS FAILURE CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 091202/T: (B)(4) ITEM MANUFACTURED AND RELEASED ON 02 FEBRUARY 2011. EXPIRATION DATE: 2015-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED OF PAIN. THE SURGEON SUSPECTED IT WAS LOOSE. INTRA-OPERATIVELY IT WAS CONCLUDED THE STEM WAS LOOSE AND IT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629126 QUADRA-H CEMENTLESS, HA COATED STEM SIZE 5 LAT CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 091202/T 07630030802171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention