BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM MONOBLOACK LPS TIBA, SIZE: 6-10

    MDR report key: 3775916 · Received April 21, 2014

    Report

    Report Number
    3005751028-2014-00028
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 15, 2011
    Report Date
    April 21, 2014
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    JWH
    PMA / PMN Number
    K020295
    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 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 PT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OD THE NEXGEN LPS-FLEX FEMORAL COMPONENT. IT WAS REPORTED BY THE PATIENT'S COUNSEL THAT THE PATIENT RECEIVED AN IMPLANT ON (B)(6) 2010 AND WAS REVISED ON (B)(6) 2011 DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241449 NEXGEN TM MONOBLOACK LPS TIBA, SIZE: 6-10 TM MONOBLOCK TIBIA JWH ZIMMER TRABECULAR METAL TECHNOLOGY

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention