BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAGNER SL REVISION STEM

    MDR report key: 4193534 · Received August 8, 2014

    Report

    Report Number
    9613350-2014-03766
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 29, 2014
    Report Date
    July 16, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION, IT IS RETAINED BY THE PATIENT. X-RAYS AND PICTURES OF THE DEVICE HAVE BEEN SUBMITTED FOR REVIEW. THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE CONFORMING. AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE AND AN INVESTIGATION RESULT IS AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT A WAGNER REVISION STEM WAS IMPLANTED IN (B)(6) 2011 ON THE LEFT SIDE. IT IS ALSO REPORTED THAT REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) 2014 DUE TO BREAKAGE OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472995 WAGNER SL REVISION STEM WAGNER SL REVISION STEM LATERAL KWA ZIMMER GMBH NA 2522892

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R