BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD+ 12.5MM

    MDR report key: 1210510 · Received October 22, 2008

    Report

    Report Number
    1818910-2008-04394
    Event Type
    Injury
    Date Received
    October 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 1

    PT WAS REVISED. PHOTOS OF EXPLANTED DEVICES SHOW EVIDENCE OF WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT STD+ 12.5MM 87NJL NJL DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC NA B2NJF4000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention