BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER NEXGEN LPS

    MDR report key: 6108934 · Received November 15, 2016

    Report

    Report Number
    MW5066090
    Event Type
    Injury
    Date Received
    November 15, 2016
    Date of Event
    March 8, 2010
    Report Date
    November 15, 2016
    Manufacturer
    ZIMMER
    Product Code
    OIY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT ON (B)(6)2010 HE HAD SURGERY TO HAVE THE ZIMMER NEXGEN LPS DEVICE IMPLANTED. AFTER THE SURGERY HE HAS EXPERIENCED EXTREME PAIN AND DIFFICULTY WALKING. HE HAS HAD 2 REVISION SURGERIES ONE IN (B)(6) 2012, AND ONE IN (B)(6) 2013. IN (B)(6) 2014, HE WENT TO A NEW PHYSICIAN WHO TOLD HIM THAT THEY NEED TO REMOVE THE DEVICE AND REPLACE IT WITH A "STRYKER ONE." AFTER HAVING THE STRYKER DEVICE IN PLACE HE NO LONGER HAS ANY ISSUES. HE IS CURRENTLY PLANNING TO PURSUE LEGAL ACTION AGAINST ZIMMER. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753960 ZIMMER NEXGEN LPS ZIMMER NEXGEN LPS OIY ZIMMER 61425092, 61080014, 61319942

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other