BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+1.5

    MDR report key: 2230586 · Received September 1, 2011

    Report

    Report Number
    1818910-2011-16963
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    June 27, 2011
    Report Date
    August 3, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    LPH
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT EXPERIENCED PAIN AND LACK OF MOBILITY WHICH REQUIRED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12/14 ARTICUL 40MM M SPEC+1.5 FEMORAL HEAD HIP IMPLANT LPH DEPUY INTERNATIONAL 2724298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention