BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY DUOFIX MBT TRAY SZ 4

    MDR report key: 3232420 · Received July 18, 2013

    Report

    Report Number
    1818910-2013-21480
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    PP830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING INVESTIGATION BY BIOENGINEERING, IT WAS CONCLUDED THAT: IT IS LIKELY IN THIS CASE THAT AN UNKNOWN COMBINATION OF SEVERAL FACTORS OCCURRED ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    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 PERFORMED DUE TO LIGAMENT INSTABILITY AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335704 DEPUY DUOFIX MBT TRAY SZ 4 TIBIAL TRAY NJL 9616671 DEPUY (IRELAND) 3069762

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention