BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY METAL LINER

    MDR report key: 1802308 · Received August 10, 2010

    Report

    Report Number
    1818910-2010-05665
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    VOLUNTARY REPORT STATES: I HAD A RIGHT TOTAL HIP REPLACEMENT - DEPUY PINNACLE METAL-ON-METAL IN 2006. IN 2009, THE DEVICE BEGAN TO FALL CAUSING METAL, CHROMIUM AND COBALT, IONS TO LEACH INTO MY SYSTEM. REVISION TOTAL HIP REPLACEMENT TO REMOVE DEPUY AND REPLACE WITH DIFFERENT BRAND DEVICE IN 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY METAL LINER TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention