BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD+ 10MM

    MDR report key: 3242896 · Received July 23, 2013

    Report

    Report Number
    1818910-2013-21909
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    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.

    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

    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.

    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 WWCAPA (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. 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

    LCS DUOFIX REVISION DUE TO PAIN AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343855 LCS COMP RP INSERT STD+ 10MM TIBIAL INSERT NJL DEPUY ORTHOPAEDICS, INC BV10L4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention