BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAB HIP PC 12-20 MD W/CS

    MDR report key: 2920816 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-11136
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    May 18, 2011
    Report Date
    December 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MEH
    PMA / PMN Number
    PK915655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 181910-2011-10724. THIS REPORT, 1818910-2013-11136, WILL BE REJECTED. 181910-2011-10724 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    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

    MEDICAL RECORDS RECEIVED FROM LEGAL ON (B)(6) 2012 INDICATED THAT THE PATIENT WAS REVISED BECAUSE OF OSTEOLYSIS, WEAR OF THE LINER AND NO BONY INGROWTH ON THE STEM. THIS WAS NOT PART OF THE LITIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27058 STAB HIP PC 12-20 MD W/CS TOTAL HIP REPLACEMENT MEH DEPUY ORTHOPAEDICS, INC. R5NA11002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention