BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIGLIANI/FLATOW HUMERAL STEM

    MDR report key: 5495599 · Received March 11, 2016

    Report

    Report Number
    1822565-2016-00615
    Event Type
    Injury
    Date Received
    March 11, 2016
    Report Date
    February 15, 2016
    Manufacturer
    ZIMMER INC
    Product Code
    KWR
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 NUMBER IS UNKNOWN. THIS DEVICE IS 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. PRODUCT HISTORY SEARCH CANNOT BE COMPLETED AND COMPATIBLY CANNOT BE VERIFIED SINCE THE PART AND LOT NUMBER IS UNKNOWN. PATIENT¿S ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTP://WWW.JSHOULDERELBOW.ORG/ARTICLE/S1058-2746(12)00182-6/PDF. (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT HUMERAL RADIOLUCENT LINES WERE NOTED IN 3 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150771 UNKNOWN BIGLIANI/FLATOW HUMERAL STEM SHOULDER PROSTHESIS KWR ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other