BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY

    MDR report key: 3150427 · Received April 15, 2013

    Report

    Report Number
    3150427
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 15, 2013
    Manufacturer
    DEPUY
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD HER DEPUY ASR HIP IMPLANT EXPLANTED DUE TO INCREASING METAL BLOOD LEVELS AND INCREASED RISK OF TISSUE AND BONE NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161964 DEPUY ARTIFICIAL HIP JOINT JDI DEPUY DP9998902410

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O