BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HARRIS/GALANTE FEMORAL COMPONENT

    MDR report key: 5472406 · Received March 1, 2016

    Report

    Report Number
    1822565-2016-00525
    Event Type
    Injury
    Date Received
    March 1, 2016
    Report Date
    February 2, 2016
    Manufacturer
    ZIMMER INC
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. EVENT PROBLEM CODES: (B)(4). REFERENCE THE LITERATURE AT THE FOLLOWING ADDRESS: HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/3183679. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO DEVICE OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. DEVICE HISTORY RECORDS CANNOT BE REVIEWED SINCE THE PART AND LOT NUMBERS ARE UNKNOWN. THESE DEVICES ARE USED FOR TREATMENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. IN THE JOURNAL ARTICLE, IT WAS NOTED THAT THE STEMS SHOWED VERY LIMITED BONE INGROWTH, IN SPITE OF GOOD SURGICAL FIT, ABSENCE OF SCLEROTIC LINES, SUBSIDENCE, OR SIGNS OF SIGNIFICANT STRESS SHIELDING. PRODUCT HISTORY SEARCH CANNOT BE COMPLETED SINCE THE PART AND LOT NUMBER IS UNKNOWN. RELEVANT MEDICAL HISTORY AND ADHERENCE TO THE REHABILITATION PROTOCOL ARE UNKNOWN. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THREE PATIENTS' FEMORAL STEMS WERE REVISED DUE TO AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126566 UNKNOWN HARRIS/GALANTE FEMORAL COMPONENT HIP PROSTHESIS KWZ ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention