BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MM DISTAL FEMORAL AUGMENT, SIZE: F

    MDR report key: 4909793 · Received July 8, 2015

    Report

    Report Number
    3005751028-2015-00103
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    April 9, 2014
    Report Date
    July 8, 2015
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    JWH
    PMA / PMN Number
    K024161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 NEXGEN LPS FLEX FEMORAL COMPONENT. IT WAS REPORTED BY THE PATIENT'S COUNSEL THAT THE PATIENT RECEIVED THE NEXGEN LPS FLEX FEMORAL COMPONENT IMPLANT ON (B)(6) 2010 AND WAS REVISED ON (B)(6) 2012 DUE TO PAIN. AS PART OF THE INITIAL REVISION, THE PATIENT RECEIVED MULTIPLE TM AUGMENTS ON (B)(6) 2012; HOWEVER, THE PATIENT WAS REVISED AGAIN ON (B)(6) 2014, WHEREUPON ALL TM AUGMENTS WERE REMOVED DUE TO INFECTION. NOTE THAT THE NEXGEN LPS FLEX FEMORAL COMPONENT IS OF ZIMMER (B)(4) DESIGN CONTROL AND THE TM AUGMENTS ARE OF ZIMMER (B)(4) DESIGN CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441655 5MM DISTAL FEMORAL AUGMENT, SIZE: F DISTAL FEMORAL AUGMENT JWH ZIMMER TRABECULAR METAL TECHNOLOGY 62005450

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention