BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT LG 12.5MM

    MDR report key: 1933545 · Received December 17, 2010

    Report

    Report Number
    1818910-2010-10238
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 22, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S074
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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.

    Description of Event or Problem · 1

    PATIENT HAD BILATERAL REVISION DONE DUE TO PAIN AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT LG 12.5MM 87NJL NJL DEPUY ORTHOPAEDICS, INC. NA DG2HH4000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention