BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIG RPF CEM FEM SZ 2.5 RT

    MDR report key: 1945142 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-09469
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    DEPUY RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S087
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE FOUND EVIDENCE SUGGESTING MICROMOTION AND/OR LOOSENING AT THE CEMENT/IMPLANT INTERFACE WHILE IN VIVO. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE DEVICE LOOSENING. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL REPORTS AGAINST THE PRODUCT LOT CODE. 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 INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR LOOSENING PAIN, STIFFNESS AND PATELLA CREPITAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIG RPF CEM FEM SZ 2.5 RT 87 NJL NJL DEPUY RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS NA BR8G34000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention