BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA VIVACIT-E PS ARTICULAR SURFACE

    MDR report key: 3820019 · Received May 14, 2014

    Report

    Report Number
    1822565-2014-00626
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    March 4, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ZIMMER
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPATIBILITY WAS VERIFIED WITH NO ISSUES NOTED. THE PATTERN OF WEAR SUGGESTS IMPROPER ALIGNMENT. RADIOGRAPHS WERE NOT RETURNED FOR REVIEW; THEREFORE, ALIGNMENT CANNOT BE VERIFIED. CAUSE CANNOT BE DEFINITIVELY DETERMINED WITH THE INFORMATION PROVIDED. DEVICE HISTORY RECORDS WERE REVEILED AND FOUND TO BE CONFORMING. VISUAL EXAMINATION OF THE RETURNED ARTICULAR SURFACE REVEALED WEAR DAMAGE TO THE POSTERIOR ASPECT OF THE MEDIAL CONDYLE ON THE ARTICULATING SURFACE. THERE IS ALSO WEAR DAMAGE ON THE POSTEROLATERAL EDGE NEAR THE SUPERIOR SURFACE OF THE POSTERIOR STABILIZING SPINE. NO OTHER DAMAGE WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT AN IRRIGATION AND DEBRIDEMENT. DURING THE PROCEDURE, THE SURGEON NOTICED A WEAR PATTERN AND ELECTED TO PERFORM AN ARTICULAR SURFACE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289062 PERSONA VIVACIT-E PS ARTICULAR SURFACE MBH ZIMMER 62294406

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR