BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK NEXGEN LPS-FLEX KNEE IMPLANT

    MDR report key: 4626295 · Received March 20, 2015

    Report

    Report Number
    1822565-2015-00398
    Event Type
    Injury
    Date Received
    March 20, 2015
    Report Date
    February 17, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED VIA PUBLISHED LITERATURE. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTP://JBJS.ORG/CONTENT/96/21/1807. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT FIVE PATIENTS HAVE EXPERIENCED MODERATE TO SEVERE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190481 UNK NEXGEN LPS-FLEX KNEE IMPLANT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other