BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT FEMORAL STEM

    MDR report key: 3022655 · Received March 22, 2013

    Report

    Report Number
    2648920-2013-00081
    Event Type
    Injury
    Date Received
    March 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVISION DATE IS UNKNOWN, THEREFORE, AN IN-VIVO TIME CANNOT BE DETERMINED. THE TOTAL HIP CONSTRUCT WAS A METAL-ON-METAL ARTICULATION. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO FLUID AROUND THE HIP JOINT, A POSSIBLE PSEUDO TUMOR AND RAISED LEVELS OF COBALT IN HER BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119179 CPT FEMORAL STEM JDI ZIMMER 60412491

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention