BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY POLY

    MDR report key: 1945633 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-09950
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S084
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED TIBIAL INSERT FOUND UNANTICIPATED WEAR FOR A POLYETHYLENE KNEE DEVICE IMPLANTED FOR TWO MONTHS. THE ACCELERATED WEAR IS ATTRIBUTED TO THIRD BODY DEBRIS BEING INTRODUCED INTO THE JOINT SPACE. THE NOTED DEBRIS IS LIKELY ASSOCIATED WITH THE FRACTURED FEMORAL STEM. NO EVIDENCE WAS FOUND SUGGESTING TIBIAL INSERT PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    PT REVISED FOR LOOSE FEMORAL/TIBIA COMPONENTS AT CEMENT/IMPLANT AND CEMENT/BONE MANTLES, OSTEOLYSIS AND POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY POLY PFCSIG CEM FEM NJL DEPUY ORTHOPAEDICS, INC. NA Y56CM4

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention