BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POROUS NEXGEN TM PATELLA, 32MM DIA.

    MDR report key: 4279023 · Received November 19, 2014

    Report

    Report Number
    3005751028-2014-00100
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    November 19, 2008
    Report Date
    November 19, 2014
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    JWH
    PMA / PMN Number
    K011904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMPLANT'S MANUFACTURING RECORD INDICATES THAT IT WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BE OBTAINED TO FURTHER THIS INVESTIGATION, THIS REPORT SHALL BE UPDATED.

    Description of Event or Problem · 1

    THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE NEXGEN LPS-FLEX. IT IS REPORTED BY THE PATIENT'S COUNSEL THAT THE PATIENT RECEIVED A TM PATELLA AND TM MONOBLOCK TIBIA ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2008 DUE TO INSTABILITY. NOTE THAT THE NEXGEN LPS-FLEX IS ZIMMER (B)(4) DESIGN AND THE TM PATELLA AND MONOBLOCK TIBIA IS ZIMMER TMT DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750680 POROUS NEXGEN TM PATELLA, 32MM DIA. TM PATELLA JWH ZIMMER TRABECULAR METAL TECHNOLOGY 60786961

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention