BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER ZMR STEM

    MDR report key: 4539100 · Received February 20, 2015

    Report

    Report Number
    1822565-2015-00197
    Event Type
    Injury
    Date Received
    February 20, 2015
    Report Date
    January 23, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPONENT COMPATIBILITY IS UNKNOWN. NEITHER OPERATIVE NOTES NOR X-RAYS HAVE BEEN RETURNED FOR REVIEW. THE COMPONENT FIT AND ORIENTATION IS UNKNOWN. 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. WITH THE INFORMATION PROVIDED, A ROOT CAUSE ANALYSIS CANNOT BE PERFORMED. MANUFACTURING DOCUMENTATION CANNOT BE RETRIEVED AND REVIEWED AND A COMPLAINT HISTORY SEARCH OF THE MANUFACTURING LOT CANNOT BE PERFORMED. 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 PATIENT IS EXPERIENCING PAIN AND SUBSIDENCE GREATER THAN 10MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124305 UNKNOWN ZIMMER ZMR STEM HIP PROSTHESIS JDI ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other