BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS FEM 70MM STD+ RT

    MDR report key: 3172587 · Received June 17, 2013

    Report

    Report Number
    1818910-2013-19024
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 17, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES CONFIRMS THE REPORT. THE FEMORAL COMPONENT FRACTURED BETWEEN THE CONDYLES, TOWARDS THE MEDIAL SIDE, ANTERIOR OF THE MEDIAL CONDYLE, DISTAL AND MEDIAL TO THE ANTERIOR FLANGE. EXAMINATION BY DEPUY METALLURGY FINDS THE COMPONENT FRACTURED DUE TO LOW STRESS, HIGH CYCLE FATIGUE. NO MATERIAL DEFECTS OR INCLUSIONS WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THE CRACK INITIATION OR PROPAGATION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. MONITOR THROUGH TRENDING.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    UPDATE (B)(6) PRODUCT, DOI, DOR.

    Description of Event or Problem · 1

    FRACTURE OF FEMUR CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273892 LCS FEM 70MM STD+ RT FEMORAL COMPONENT NJL DEPUY ORTHOPAEDICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention