BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC C/R FEM CEM RT SZ3

    MDR report key: 1800881 · Received August 10, 2010

    Report

    Report Number
    1818910-2010-05528
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. 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 THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR LOOSE FEMORAL, TIBIAL , PATELLA/CEMENT INTERFACE FAILURE. CEMENT MFG BY OTHERS. OSTEOLYSIS AND POLYETHYLENE WEAR NOTED ON INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC C/R FEM CEM RT SZ3 JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS NA 041293

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention