BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR L LG

    MDR report key: 3022877 · Received March 27, 2013

    Report

    Report Number
    1818910-2013-14518
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    9616671 DEPUY IRELAND
    Product Code
    MBH
    PMA / PMN Number
    PP830055/
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT CONCLUDES: FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINABLE, LIMITED INFORMATION CAN BE ASCERTAINED FROM THE X-RAYS. THE LATERAL X-RAY DOES SUGGEST SOME MAL POSITIONING OF THE JOINT. IT IS NOT POSSIBLE TO COMMENT ON THE INFECTION REPORT OR LACK OF IT FROM THE X-RAYS. IT IS NOT POSSIBLE TO SAY IS THERE IS A MANUFACTURING FAULT FROM THE LIMITED INFORMATION AVAILABLE. 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 FURTHER INVESTIGATION SHALL BE 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.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED PAIN WITH POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126329 LCS COMPLETE FEM POR L LG FEMORAL COMPONENT MBH 9616671 DEPUY IRELAND 1854603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention