BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MONOBLOCK LPS TIBIA SIZE: NBR 3

    MDR report key: 1933802 · Received December 13, 2010

    Report

    Report Number
    3005751028-2010-00053
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 4, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    K020295
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR EVAL. THE REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT IT WAS MANUFACTURED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    EVENT DETAIL: THE PT REC'D A BILATERAL TKA ON (B)(6), 2008. IT WAS REPORTED THAT THE PT UNDERWENT A REVISION OF THE LEFT KNEE ON (B)(6), 2010 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MONOBLOCK LPS TIBIA SIZE: NBR 3 MONOBLOCK TIBIA JWH ZIMMER TMT 56472275

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR