BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCS COMP RP INSERT LG+ 10MM

    MDR report key: 2090730 · Received April 29, 2011

    Report

    Report Number
    1818910-2011-07456
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    NJL
    PMA / PMN Number
    P830055/S116
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    (B)(4). THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. 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

    PT WAS REVISED DUE TO REOCCURRING EFFUSIONS IN THE RIGHT KNEE FOR TWO YEARS. DISCOVERED WRONG INSERT HAD BEEN PUT IN, REMOVED AND REPLACED WITH CORRECT INSERT WHICH EXTENDED THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT LG+ 10MM 87 NJL NJL DEPUY RAYNHAM NA B5VKE4000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR