BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POROUS NEXGEN TM PATELLA, 35MM DIA.

    MDR report key: 3760812 · Received April 7, 2014

    Report

    Report Number
    3005751028-2014-00025
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    April 23, 2012
    Report Date
    April 7, 2014
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    JWH
    PMA / PMN Number
    K011904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 INFO AVAILABLE, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED. SHOULD ADD'L INFO 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 IN ADDITION TO THE NEXGEN LPS-FLEX (ZIMMER WARSAW DESIGN), THE PATIENT ALSO RECEIVED A TM MONOBLOCK TIBIA AND TM PATELLA (ZIMMER TMT DESIGN) ON (B)(6) 2007 AND WAS REVISED ON (B)(6) 2012 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205721 POROUS NEXGEN TM PATELLA, 35MM DIA. TM PATELLA JWH ZIMMER TRABECULAR METAL TECHNOLOGY 60448084

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention