BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+5

    MDR report key: 2900735 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-00755
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    May 13, 2014
    Report Date
    December 10, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED PAIN, SWELLING, INFLAMMATION, INFECTION, AND DAMAGE TO SURROUNDING BONE AND TISSUE, MULTIPLE DISLOCATIONS, AND LACK OF MOBILITY. DOI: (B)(6) 2008 - DOR: NONE REPORTED (UNKNOWN SIDE). (B)(6). UPDATE: (B)(4) 2012, PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. (RIGHT HIP)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9772 12/14 ARTICUL 40MM M SPEC+5 TOTAL HIP REPLACEMENT LPH DEPUY ORTHOPAEDICS INC US 2631049

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other| R