BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS TEX PAT STD+

    MDR report key: 2503571 · Received March 26, 2012

    Report

    Report Number
    1818910-2012-06952
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    February 29, 2012
    Report Date
    February 29, 2012
    Manufacturer
    DEPUY WARSAW
    Product Code
    NJL
    PMA / PMN Number
    P830055/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW OF PROVIDED PATIENT X-RAYS BY DEPUY INTERNATIONAL CONFIRMS LOOSENING OF THE TIBIAL TRAY. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PROVIDED PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. ETQ COMPLAINTS DATABASE SEARCHED ON PRODUCT LOT WCR-24, LHD-59, WET-95, (B)(4), KQO-04 IDENTIFIED NO PREVIOUS COMPLAINTS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT HAS HAD KNEE PAIN FOR THE LAST 3-4 YEARS, AND THE COMPONENTS HAD SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS TEX PAT STD+ KNEE NJL DEPUY WARSAW R13CA1003

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention