BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE PROVISIONAL

    MDR report key: 6078610 · Received November 4, 2016

    Report

    Report Number
    0001822565-2016-03919
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 17, 2016
    Report Date
    March 2, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED PRIOR TO THE UDI BEING REQUIRED. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RETURNED, NOT YET EVALUATED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. THERE ARE NO ALLEGATIONS OF FAILURE OF THE DEVICE AND THE INITIAL REPORT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PROVISIONAL BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731398 NEXGEN LPS-FLEX ARTICULAR SURFACE PROVISIONAL KNEE PROVISIONAL HWT ZIMMER, INC. 60706726

    Patients

    Seq Age Sex Outcome Treatment
    1