BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POROUS NEXGEN TM PATELLA, 32MM DIA.

    MDR report key: 3883876 · Received June 11, 2014

    Report

    Report Number
    3005751028-2014-00040
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    March 8, 2012
    Report Date
    June 13, 2014
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K011904
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS ALLEGING HARM CAUSED BY THE DEVICE, HOWEVER, THE NATURE OF THE HARM IS UNKNOWN AT THIS TIME. IT IS ALSO REPORTED THAT THE DEVICE APPEARS TO BE LOOSENING ON X-RAY AND HAS SHIFTED APPROXIMATELY 10 DEGREES TO THE INSIDE OF HIS LEG. IT IS UNKNOWN WHICH KNEE COMPONENT IS BEING IDENTIFIED. A REVISION SURGERY HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346085 POROUS NEXGEN TM PATELLA, 32MM DIA. TM PATELLA JWH ZIMMER TMT 61952746

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention