BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-STEM CDH

    MDR report key: 1335515 · Received February 27, 2009

    Report

    Report Number
    1818910-2009-00977
    Event Type
    Injury
    Date Received
    February 27, 2009
    Date of Event
    February 12, 2009
    Report Date
    February 12, 2009
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    JDI
    PMA / PMN Number
    K982918
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-STEM CDH 87JDI JDI DEPUY INTERNATIONAL LTD. NA XMA15

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention