BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA PRIMARY FEM STEM #3 RIGHT

    MDR report key: 2941858 · Received February 4, 2013

    Report

    Report Number
    0002249697-2013-00536
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    July 4, 2012
    Report Date
    January 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K852964
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS THE DEVICES WERE NOT MADE AVAILABLE FOR EVALUATION AND NO MEDICAL INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    THE VIGILANCE RESPONSIBLE OF THE HOSPITAL, DR (B)(6), REPORTED AN EVENT OF LOOSENING OF THE IMPLANTED PRODUCTS. THE PATIENT INVOLVED UNDERWENT A SURGICAL PROCEDURE OF THR ON (B)(6) 1997 DUE TO COXARTHRITIS. ON (B)(6) 2012 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF ALL THE IMPLANTED DEVICE. THE DEVICE IMPLANTED WAS PCA STEM AND THE REST OF ITEMS WERE OF A COMPETITOR.

    Description of Event or Problem · 1

    THE VIGILANCE RESPONSIBLE OF THE HOSPITAL, DR (B)(6), REPORTED AN EVENT OF LOOSENING OF THE IMPLANTED PRODUCTS. THE PATIENT INVOLVED UNDERWENT A SURGICAL PROCEDURE OF THR ON (B)(6) 1997 DUE TO COXARTHRTIS. ON (B)(6) 2012, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF ALL THE IMPLANTED DEVICE. THE DEVICE IMPLANTED WAS PCA STEM AND THE REST OF ITEMS WERE OF A COMPETITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46061 PCA PRIMARY FEM STEM #3 RIGHT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention