BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD 10MM

    MDR report key: 1923695 · Received December 9, 2010

    Report

    Report Number
    1818910-2010-09379
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 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
    AS
    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

    CORRECTIVE AND PREVENTATIVE ACTIONS ARE BEING MANAGED VIA (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.

    Description of Event or Problem · 1

    KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMP RP INSERT STD 10MM 87 NJL NJL DEPUY ORTHOPAEDICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention