BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT STD+ 10MM

    MDR report key: 2926253 · Received January 23, 2013

    Report

    Report Number
    1818910-2013-11359
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 23, 2013
    Manufacturer
    DEPUY-RAYNHAM
    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

    THE LCS DUO-FIX FEMORAL COMPONENTS WERE VOLUNTARILY RECALLED FROM THE MARKET IN JULY 2009, AND THE LCS DUO-FIX FEMORAL PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INSPECTION OF COMPONENTS WILL NOT BE PERFORMED AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (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. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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.

    Description of Event or Problem · 1

    REVISION OF RIGHT LCS DUOFIX COMPONENT. UPDATE JAN 23, 2013: REVISED FOR PAIN AND TENDERNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32430 LCS COMP RP INSERT STD+ 10MM TIBIAL INSERT NJL DEPUY-RAYNHAM B3XG94000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention