BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF CEM FEM SZ 2 RT

    MDR report key: 2151172 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-11300
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    NJL
    PMA / PMN Number
    P830055/S087
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICES FOUND EVIDENCE SUGGESTING DEVICE LOOSENING IN VIVO. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DEVICE LOOSENING. NO EVIDENCE WAS FOUND SUGGESTING 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.

    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

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG RPF CEM FEM SZ 2 RT 87NJL NJL DEPUY RAYNHAM NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention