BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS TEX ROT PLAT TIB PLAT STD+

    MDR report key: 2002383 · Received February 18, 2011

    Report

    Report Number
    1818910-2011-02641
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 ADD'L REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFO. 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 HAD BILATERAL KNEE REVISIONS DUE TO TIBIAL TRAY SUBSIDENCE. THERE WAS LOOSENING OF THE RIGHT KNEE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE. THERE WAS LOOSENING OF THE LEFT KNEE TIBIAL TRAY AT THE CEMENT/BONE INTERFACE. THE MFR OF THE CEMENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS TEX ROT PLAT TIB PLAT STD+ 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA 955924

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention