BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS MENIS BEARING LG/10MM

    MDR report key: 1040008 · Received May 6, 2008

    Report

    Report Number
    1818910-2008-01782
    Event Type
    Injury
    Date Received
    May 6, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P910016/S005
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. PRODUCT INFO REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION WAS LIMITED TO THE INFO PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED POLYETHYLENE WEAR/FRACTURE; HOWEVER, THE LENGTH OF TIME THE DEVICE WAS IMPLANTED (20 YEARS) WAS A LIKELY CONTRIBUTING FACTOR. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IN ADDITION, THE PRODUCT CODE IS A DISCONTINUED ITEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCTS AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF WEAR WITH A PIECE OF THE POLY BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS MENIS BEARING LG/10MM 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention