BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS TEX PAT STD+

    MDR report key: 1913876 · Received November 30, 2010

    Report

    Report Number
    1818910-2010-08545
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 7, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P910016/S005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS UNAVAILABLE AND OR NON-VERIFIABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED POLY WEAR. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    REVISION OF A KNEE IMPLANTED (B)(6) 1996. REVISED ON THE (B)(6) 2010 NB POROCOAT FEMUR WAS CEMENTED IN 1996. UPDATE: IN A F/U WITH THE REP, IT IS STATED THE REASON FOR REVISION IS POLY WEAR - (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS TEX PAT STD+ 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA 692990020

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention