BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-STEM CDH

    MDR report key: 516536 · Received March 18, 2004

    Report

    Report Number
    1818910-2004-00185
    Event Type
    Injury
    Date Received
    March 18, 2004
    Date of Event
    February 7, 2004
    Report Date
    February 24, 2004
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    C-STEM BROKEN IN 2004. NO SIGNIFICANT TRAUMA. REQUIRES REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-STEM CDH TOTAL HIP REPLACEMENT JDI DEPUY INTERNATIONAL, LTD. NA WXV97

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention