BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA/OV/DOME PAT 3PEG,35

    MDR report key: 1040011 · Received May 6, 2008

    Report

    Report Number
    1818910-2008-01777
    Event Type
    Injury
    Date Received
    May 6, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MFG LOTS. PROVIDED INFO STATED THE CEMENT WAS NOT A DEPUY PRODUCT. THE INITIAL REPORTING INDICATED THE PRODUCTS WERE NOT SUSPECTED OF FAILING TO MEET SPECS OR CONTRIBUTING TO THE EVENT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE LOOSENING OR POLYETHYLENE WEAR. 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 PRODUCTS AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF LOOSENING AT THE IMPLANT/CEMENT INTERFACE WITH POLY WEAR. THE CEMENT WAS COMPETITORS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA/OV/DOME PAT 3PEG,35 87JWH JWH DEPUY-RAYNHAM, A DIVISION OF ORTHOPAEDICS, INC. NA 273212

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention