BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPT HIP SYSTEM FEMORAL STEM

    MDR report key: 3874377 · Received April 18, 2014

    Report

    Report Number
    2648920-2014-00093
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE TRIAL HEADS STUCK ON THE CEMENTED STEM. WHILE TRYING TO REMOVE IT CAUSED THE STEM TO BECOME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238453 CPT HIP SYSTEM FEMORAL STEM JDI ZIMMER 62563933

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 32MM TRIAL HEADS, CATALOG UNK, LOT UNK