BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FITMORE HIP STEM

    MDR report key: 1965575 · Received January 14, 2011

    Report

    Report Number
    9613350-2011-00031
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    October 7, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT CANNOT BE CONFIRMED AT THIS TIME IF THE PRODUCTS IMPLANTED WERE ZIMMER PRODUCTS. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNK. THERE IS INSUFFICIENT INFORMATION TO PERFORM A PROBABLE CAUSE ANALYSIS. BASED ON THE GIVEN INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FITMORE HIP STEM ZIMMER POROLOCK MIS STEM JDI ZIMMER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other