BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA STB INS S2.5 10MM

    MDR report key: 1080172 · Received July 21, 2008

    Report

    Report Number
    1818910-2008-02947
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 2008
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K952830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS SNOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MANUFACTURING LOTS. 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

    PT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY, POLY WEAR, AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA STB INS S2.5 10MM 87JWH JWH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 1129838

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention