BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMP RP INSERT LG 10MM

    MDR report key: 3810288 · Received May 14, 2014

    Report

    Report Number
    1818910-2014-18780
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    November 26, 2013
    Report Date
    March 3, 2015
    Manufacturer
    DEPUY-RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS 1219655
    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

    ADDITIONAL NARRATIVE: 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. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REMAINS CLOSED, AS THE NEW INFORMATION DOES NOT AFFECT THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE: LCS DUOFIX REVISION. ORIGINALLY IMPLANTED ON (B)(6) 2009. REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 BY THE SAME SURGEON AND AT THE SAME HOSPITAL. REASON FOR REVISION: METALLOSIS AND CONSEQUENTLY OSTEOLYSIS. THERE WAS SIGNIFICANT BONE LOSS ON THE MEDIAL SIDE OF THE FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288874 LCS COMP RP INSERT LG 10MM KNEE TIBIAL BEARING/INSERT NJL DEPUY-RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS 1219655 C52KG4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention