BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT CEM TIBIAL TRAY SZ4

    MDR report key: 1772276 · Received July 22, 2010

    Report

    Report Number
    1818910-2010-04616
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 22, 2010
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    P830055/S108
    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

    PATIENT PRESENTED WITH SWELLING PAIN AND STIFFNESS AND INFECTION FOR MORE THAN 12 MONTHS ON LEFT KNEE. DURING REVISION METALLOSIS WAS NOTED AND SCARRING OR MARKING ON IMPLANT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MBT CEM TIBIAL TRAY SZ4 NJL DEPUY (IRELAND) NA 2816028

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention