BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR6-10

    MDR report key: 3170429 · Received June 10, 2013

    Report

    Report Number
    3005751028-2013-00053
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ZIMMER TRABECULAR METAL TECHNOLOGY
    Product Code
    JWH
    PMA / PMN Number
    K012866
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. THE IMPLANT REMAINS WITHIN THE PATIENT AND NO REVISION SURGERY HAS BEEN SCHEDULED AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED TO FURTHER THIS INVESTIGATION, THIS REPORT SHALL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED DIRECTLY FROM THE CONSUMER THAT HE IS EXPERIENCING PAIN IN HIS LEFT KNEE. AT THIS TIME THERE HAS BEEN NO REVISION AND IT IS UNK IF ONE HAS BEEN PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261398 NEXGEN TM MONOBLOCK CR TIBIA SIZE NBR6-10 TM MONOBLOCK TIBIA JWH ZIMMER TRABECULAR METAL TECHNOLOGY 60936511

    Patients

    Seq Age Sex Outcome Treatment
    1