BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS 3 PEG ROT PATELLA CEM LG

    MDR report key: 2141286 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-11003
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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 PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. 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

    DURING A REVISION SURGERY TO ADDRESS LOOSENING OF COMPONENTS AT CEMENT/BONE INTERFACE WITH COMPETITOR'S CEMENT USED IN THE PRIMARY SURGERY, POLY WEAR WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS 3 PEG ROT PATELLA CEM LG 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA U65B8A009

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention