BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFCSIG CEM FEM STEM 5DG13X90MM

    MDR report key: 6087318 · Received November 8, 2016

    Report

    Report Number
    1818910-2016-31106
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    September 19, 2016
    Report Date
    November 2, 2016
    Manufacturer
    DEPUY-RAYNHAM 1219655
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). (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 SUBMITTED DEVICE CONFIRMED FRACTURE DUE TO LOW-STRESS, HIGH-CYCLE FATIGUE. THERE WAS NO EVIDENCE OF INCLUSIONS OR OTHER MATERIAL DEFECTS THAT COULD HAVE CONTRIBUTED TO CRACK INITIATION OR PROPAGATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR TO THE REPORTED EVENT AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN, OSTEOLYSIS AND A BROKEN ADAPTOR BOLT AND LOOSE FEMORAL COMPONENT. LOOSENING OCCURRED AT THE BONE/CEMENT IMPLANT INTERFACE. CEMENT MANUFACTURED BY A COMPETITOR. UPDATE 11/2/2016: EXAMINATION OF THE SUBMITTED DEVICES FOUND THE STEM BOLT AND STEM FRACTURED. THE STEM HAS NOW BEEN ADDED AND REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738114 PFCSIG CEM FEM STEM 5DG13X90MM KNEE OTHER IMPLANT NJL DEPUY-RAYNHAM 1219655 316349R

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention