BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD+ 12.5MM

    MDR report key: 1111746 · Received August 13, 2008

    Report

    Report Number
    1818910-2008-03071
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED. A SEARCH OF THE WARSAW AND INTERNATIONAL COMPLAINT DATABASE DID NOT FIND ANY ADDITIONAL REPORTS OF THIS NATURE FOR THE PRODUCT CODE/LOTS PROVIDED SINCE THEIR RESPECTIVE RELEASE FOR DISTRIBUTION. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, INFORMATION PROVIDED IN THE INITIAL REPORT SUGGESTS THAT THE IMPLANT SIZE CHOSEN FOR THE INITIAL SURGERY DID NOT ACHIEVE THE DESIRED RESULTS. NO EVIDENCE WAS FOUND THAT WOULD SUGGEST PRODUCT ERROR WAS A CONTRIBUTING FACTOR. THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ANY ADDITIONAL INFO BE REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION OF THE BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT STD+ 12.5MM 87NJL NJL DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM NA CL2DV4000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention