BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAGNER REVISION STEM

    MDR report key: 5214357 · Received November 10, 2015

    Report

    Report Number
    9613350-2015-01869
    Event Type
    Injury
    Date Received
    November 10, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 20, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, 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 INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, THAT A PATIENT WAS IMPLANTED AN UNKNOWN WAGNER REVISION STEM ON AN UNKNOWN DATE. THE PATIENT UNDERWENT A REVISION SURGERY ON AN UNKNOWN DATE DUE TO UNKNOWN REASONS. (JOURNAL ARTICLE: MALLMIN, HANS: A CROSS-SECTIONAL STUDY WITH 6-20 YEARS FOLLOW -UP OF UNCEMENTED WAGNER REVISION STEMS. REOPERATIONS BONE MINERAL DENSITY, BMD AND CLINICAL EVALUATION, IN: ABSTRACTS FROM 11TH EHS CONGRESS STOCKHOLM - SWEDEN, 9 - 11 OCTOBER 2014)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745276 WAGNER REVISION STEM WAGNER REVISION STEM JDI ZIMMER GMBH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R