BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED PROLONG HIGHLY CR

    MDR report key: 1200654 · Received October 16, 2008

    Report

    Report Number
    1822565-2008-00701
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2007. THE DEVICE WAS REVISED IN 2008, DUE TO THE CEMENT MANTLE ON THE TIBIA BREAKING. WHEN THE SURGEON WENT IN TO REVISE, IT WAS NOTICED THAT THERE WAS MAJOR POLY WEAR ON THE ARTICULATING SURFACE. THE DOCTOR WAS CONCERNED AND REVISED THE ENTIRE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-POSTERIOR STABILIZED PROLONG HIGHLY CR KNEE PROSTHESIS JWH ZIMMER, INC. NA 60490643

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R CATALOG #00598604701 NEXGEN COMPLETE KNEE| SOLUTION STEMMED NONAUGMENTABLE TIBIAL COMPONENT| LOT #60660872 WAS MANUFACTURED AT ZIMMER MFG B.V.