BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE M/B PAT CEM STD

    MDR report key: 1870912 · Received October 7, 2010

    Report

    Report Number
    1818910-2010-07283
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S113
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 OTHER REPORTS AGAINST THE LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED DEVICE DISLOCATION; HOWEVER, THE INITIAL REPORTING STATED THE PATIENT EXPERIENCED TRAUMA (FELL) WHICH WAS A CONTRIBUTING FACTOR. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE REPORT STATES: THE PATIENT FELL AND DISLOCATED THE PATELLA COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE M/B PAT CEM STD 87NJL NJL DEPUY INTERNATIONAL, LTD. NA 2599333

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention