BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 5545630 · Received April 4, 2016

    Report

    Report Number
    2648920-2016-00097
    Event Type
    Injury
    Date Received
    April 4, 2016
    Report Date
    March 9, 2016
    Manufacturer
    ZIMMER, TURPEAUX INDUSTRIAL PARK
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) OTHER DEVICES USED: CATALOG #00597206535, NEXGEN ALL POLY PATELLA, LOT #61716012. CATALOG #00596401651, NEXGEN LPS-FLEX FEMORAL COMPONENT, LOT #61672255; MANUFACTURED AT ZIMMER BIOMET INC., (B)(4). CATALOG #00596204012, NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE, LOT #60923387; MANUFACTURED AT ZIMMER BIOMET INC., (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, SHIFTING OF THE KNEE AND THE KNEE LOCKING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202126 NEXGEN STEMMED TIBIAL COMPONENT JWH JWH ZIMMER, TURPEAUX INDUSTRIAL PARK 61618386

    Patients

    Seq Age Sex Outcome Treatment
    1 Other