BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY DUOFIX MBT TRAY SZ 5

    MDR report key: 3905020 · Received July 1, 2014

    Report

    Report Number
    1818910-2014-22381
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    December 9, 2013
    Report Date
    June 27, 2014
    Manufacturer
    DEPUY IRELAND-9616671
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE LCS DUOFIX FEMORAL COMPONENTS WERE VOLUNTARILY RECALLED FROM THE MARKET IN JULY 2009, AND THE LCS DUOFIX FEMORAL PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INSPECTION OF COMPONENTS WILL NOT BE PERFORMED AS THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS ARE CONTROLLED UNDER (B)(4). WHERE INDIVIDUAL RETRIEVAL ANALYSIS IS UNDERTAKEN TO CONFIRM THE PRESENCE OF ALUMINA IN THE POLY BEARING SURFACE THEN THESE REVIEWS WILL BE ATTACHED TO THE COMPLAINT RECORD ON RECEIPT OF THE APPROVED DOCUMENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PROCEDURE: LCS DUOFIX REVISION - LEFT KNEE. ORIGINALLY IMPLANTED ON (B)(6) 2009. REVISION SURGERY PERFORMED ON (B)(6) 2013 BY THE SAME SURGEON. UPDATE (B)(6) 2013 REASON FOR REVISION METALOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384826 DEPUY DUOFIX MBT TRAY SZ 5 KNEE TIBIAL TRAY NJL DEPUY IRELAND-9616671 2588562

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention