BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK AVENIR STEM

    MDR report key: 3934645 · Received June 26, 2014

    Report

    Report Number
    9613350-2014-03668
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE THE DEVICE, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REF # OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS IMPLANTED WITH A AVENIR STEM (EXACT CATALOG NUMBER UNK) ON UNK DATE AND WAS REVISED ON UNK DATE DUE TO STEM SUBSIDENCE (AROUND 1CM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374260 UNK AVENIR STEM UNK AVENIR STEM JDI ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R