BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POROUS NEXGEN TM PATELLA, 38MM DIA.

    MDR report key: 4909806 · Received July 8, 2015

    Report

    Report Number
    3005751028-2015-00102
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    May 4, 2015
    Report Date
    July 8, 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

    IT IS REPORTED THAT THE PATIENT RECEIVED A TKA ON (B)(6) 2014. THE PATIENT REPORTS PAIN AND DISCOMFORT AND IS CONSIDERING A REVISION SURGERY; HOWEVER, AT THIS TIME, NO REVISION HAS BEEN SCHEDULED/PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441816 POROUS NEXGEN TM PATELLA, 38MM DIA. TM PATELLA JWH ZIMMER TRABECULAR METAL TECHNOLOGY 62304929

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other