BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POROUS NEXGEN TM PATELLA, 35MM DIA.

    MDR report key: 2801465 · Received October 11, 2012

    Report

    Report Number
    3005751028-2012-00139
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    July 9, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K011904
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMPLANT'S MFG 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

    IT WAS REPORTED BY THE PT'S LEGAL COUNSEL THAT THE PT REC'D A TKA ON (B)(6) 2009. ON (B)(6) 2012, THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POROUS NEXGEN TM PATELLA, 35MM DIA. TM PATELLA JWH ZIMMER TMT 61230416

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention