BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT

    MDR report key: 6130181 · Received November 28, 2016

    Report

    Report Number
    0002648920-2016-04364
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    October 31, 2016
    Report Date
    July 14, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS MISSING AN INITIAL REPORT IN SEQUENCE, THEREFORE MEDWATCH# 0002648920-2017-00453 WAS CREATED TO ADDRESS THIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON NOTICED SMALL QUANTITIES OF METAL DEBRIS PRIOR TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779099 NEXGEN STEMMED NONAUGMENTABLE TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 63308752

    Patients

    Seq Age Sex Outcome Treatment
    1