BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POROUS NEXGEN TM PATELLA, 32MM DIA.

    MDR report key: 4943403 · Received July 23, 2015

    Report

    Report Number
    3005751028-2015-00111
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    June 2, 2015
    Report Date
    July 23, 2015
    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 PERSONA TM TIBIAL COMPONENT. IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT ON (B)(6) 2014 AND EXPERIENCES PAIN, CLICKING, AND AN UNNATURAL WALKING GAIT. RECENT X-RAYS SHOW THE BONE IS NOT GROWING INTO THE TIBIAL COMPONENT. A REVISION SURGERY IS SCHEDULED FOR (B)(6) 2015. THE PATIENT WAS ALSO IMPLANTED WITH A TM PATELLA ON (B)(6) 2014; HOWEVER, NO ISSUES HAVE BEEN OBSERVED WITH THIS COMPONENT AND NO REVISION IS PLANNED FOR THE TM PATELLA. THE PERSONA TM TIBIAL COMPONENT IS OF ZIMMER (B)(4) DESIGN CONTROL AND THE TM PATELLA IS OF ZIMMER TMT DESIGN CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480575 POROUS NEXGEN TM PATELLA, 32MM DIA. TM PATELLA JWH ZIMMER TRABECULAR METAL TECHNOLOGY 62593968

    Patients

    Seq Age Sex Outcome Treatment
    1 Other