BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD+ 12.5MM

    MDR report key: 1220349 · Received November 3, 2008

    Report

    Report Number
    1818910-2008-04793
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED, AS THE LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT BASED ON THE PROVIDED INFORMATION. THE INITIAL REPORT STATES THAT IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS OR CONTRIBUTED TO THE REPORTED EVENT. 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 TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED BECAUSE OF PAIN. THE KNEE WAS UNSTABLE MEDIALLY AND LATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT STD+ 12.5MM 87NJL NJL DEPUY ORTHOPAEDICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention