BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE SOLUTION

    MDR report key: 7411416 · Received April 9, 2018

    Report

    Report Number
    MW5076386
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    May 21, 2014
    Report Date
    April 20, 2018
    Manufacturer
    ZIMMER INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BILATERAL PATELLOFEMORAL ARTHROPLASTIES ON (B)(6) 2014 AND THEY BOTH FAILED THREE MONTHS LATER CAUSING ME EXCRUCIATING KNEE PAIN AND INABILITY TO WALK. EVERY TIME I WENT BACK TO THE SURGEON, THE X-RAYS SHOWED THAT THE IMPLANTS WERE IN PLACE. FINALLY AFTER ABOUT 11 MONTHS THE X-RAYS FINALLY SHOWED BONE ON BONE AND I WAS TOLD THAT I NOW NEEDED REVISION TOTAL KNEE REPLACEMENTS. I HAD A REVISION LTK REPLACEMENT ON (B)(6) 2015 AND A REVISION TRK REPLACEMENT ON (B)(6) 2016. FOR ALMOST 3 YEARS NOW, THERE IS A LARGE SWOLLEN AREA ON THE LATERAL SIDE OF MY LEFT KNEE. I HAVE PAIN DESCENDING STEPS, TRYING TO DO SQUATS AND AFTER STANDING FOR MORE THAN 15 MINUTES. ON (B)(6) 2017 MY LEFT KNEE WENT OUT ON ME WITHOUT WARNING WHILE ON MY STAIRS, RESULTING IN FALLING. ON (B)(6) 2017, MY LEFT KNEE WENT OUT ON ME AGAIN WITHOUT ANY WARNING, RESULTING IN ME FALLING ON MY KITCHEN FLOOR. ALL THE KNEE SURGERIES WERE PERFORMED BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER FOR REPORT MW5076386 ON 04/20/2018. REPORTER HAS ADDED ADDITIONAL DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248824 NEXGEN COMPLETE KNEE SOLUTION PROSTHESIS, KNEE JWH ZIMMER INC. 62562104
    248830 GENDER SOLUTION PATELOFEMORAL PROSTHESIS KNEE JWH ZIMMER, INC. 62558843
    248831 GENDER SOLUTION PATELOFEMORAL PATELLOFORMAL COMPONENT JWH ZIMMER, INC 62549285
    248832 TOTAL KNEE REPLACEMENT PERSONA PERSONALIZE KNEE SYSTEM FEMORAL COMPONENT JWH ZIMMER INC. 62275444
    248833 TOTAL KNEE REPLACEMENT PERSONA PERSONALIZE KNEE SYSTEM ARTICULAR SURFACE JWH ZIMMER INC. 62715738
    248834 TOTAL KNEE REPLACEMENT PERSONA PERSONALIZE KNEE SYSTEM TIBIAL COMPONENT JWH ZIMMER, INC. 62928744

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR