BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM 3 LAT

    MDR report key: 5991609 · Received September 30, 2016

    Report

    Report Number
    3005180920-2016-00505
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 13 SEPTEMBER 2016, (B)(4) (MANUFACTURER OF THE CERAMIC PRODUCT INVOLVED IN THIS COMPLAINT, NOT MARKET IN USA) HAS BEEN INFORMED ABOUT THE COMPLAINT. ON 15 SEPTEMBER 2016, (B)(4) PROVIDED A DOCUMENT REVIEW REPORTING AS FOLLOWS: THE COMPONENT PROPERTIES AND MICROSTRUCTURE AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION. THERE ARE NO-INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT OR NON-CONFORMITIES REGARDING STERILIZATION. DUE TO A LACK OF CERAMIC PARTS FURTHER INVESTIGATIONS CAN NOT BE DONE. BATCH REVIEW PERFORMED ON 28 SEPTEMBER 2016. LOT 140260: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 APRIL 2014. EXPIRATION DATE: 2019-02-28. 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. NOT YET RECEIVED.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO INFECTION. THE STEM AND THE HEAD WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643836 QUADRA-H CEMENTLESS, HA COATED STEM 3 LAT CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 140260

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention