BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT LG 12.5MM

    MDR report key: 1842578 · Received September 17, 2010

    Report

    Report Number
    1818910-2010-06310
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIVE AND PREVENTATIVE ACTIONS ARE BEING MANAGED VIA WWCAPA (B)(4). THERE WAS NO INDICATION OF DEVIATIONS OR ANOMALIES WITH REGARD TO MATERIAL SPECIFICATION OR INSPECTION SO NO REVIEW OF THE DHR WILL BE CARRIED OUT AT THIS POINT IN TIME. 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.

    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

    SCRATCHING LEAD TO PAIN AND SWELLING. THE PT WAS SCOPED AND DEVELOPED AN INFECTION. THE IMPLANTS THEN WERE TAKEN OUT AND A SPACER PUT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT LG 12.5MM NJL DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA A66JB4000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention