BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM CEM L LG

    MDR report key: 1581332 · Received January 14, 2010

    Report

    Report Number
    1818910-2009-08150
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    December 15, 2009
    Report Date
    December 15, 2009
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE FOR THE REPORTED FEMORAL COMPONENT DID NOT SHOW ANY OTHER REPORTS AGAINST THE MANUFACTURING LOT. THE CEMENT PRODUCT WAS OF DEPUY COMPETITOR MANUFACTURE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED LOOSENING; HOWEVER, PROVIDED INFORMATION STATED THE SIZE DEVICE INSERTED AT PRIMARY SURGERY 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

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AT THE CEMENT/BONE INTERFACE. IT WAS REPORTED THAT THE FEMORAL WAS OVERSIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE FEM CEM L LG 87NJL NJL DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 1197093

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention