BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA MOD TIB TRAY CEM SZ4

    MDR report key: 1153060 · Received September 5, 2008

    Report

    Report Number
    1818910-2008-03905
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K884796
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED, AS THE PRODUCT CODE AND LOT NUMBERS REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY WERE NOT PROVIDED. ALTHOUGH THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION, INFECTION AFTER APPROX. ELEVEN YEARS IMPLANTATION IS UNLIKELY PRODUCT ERROR RELATED. THE INITIAL REPORT STATES THAT IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF INFECTION WITH LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA MOD TIB TRAY CEM SZ4 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention