BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR R STD+

    MDR report key: 2002701 · Received February 17, 2011

    Report

    Report Number
    1818910-2011-02562
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    MBH
    PMA / PMN Number
    P830055/S073
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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; HOWEVER, THE INITIAL REPORTING STATED THE FEMUR WAS IN POOR POSITION. PROVIDED INFO STATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECS OR BEING A CONTRIBUTING FACTOR TO THE EVENT. 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 WAS REVISED TO ADDRESS PAIN RELATED TO A VALGUS POSITIONED FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE FEM POR R STD+ 87MBH MBH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 2014707

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention