BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE M/B PAT CEM STD+

    MDR report key: 1000393 · Received February 19, 2008

    Report

    Report Number
    1818910-2008-00384
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 29, 2008
    Manufacturer
    DEPUY-CORK A DIV OF DEPUY ORTHOPAEDICS
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE AS NO PROD WAS RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT FIND ANY ADD'L REPORTS OF THIS NATURE FOR THE PROD CODE/LOTS PROVIDED SINCE THEIR RESPECTIVE RELEASE FOR DISTRIBUTION. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, INFO PROVIDED IN THE INITIAL REPORT SUGGESTS THAT THE IMPLANT SIZE CHOSEN FOR THE INITIAL SURGERY DID NOT ACHIEVE THE DESIRED RESULTS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PROD AND/OR ADD'L INFO BE REC'D TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS STIFFNESS AND LOSS OF RANGE OF MOTION. POLY WEAR OF THE INSERT WAS NOTED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE M/B PAT CEM STD+ 87NJL NJL DEPUY-CORK A DIV OF DEPUY ORTHOPAEDICS NA 2177295

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention