BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX ARTICULAR SURFACE

    MDR report key: 2932494 · Received January 24, 2013

    Report

    Report Number
    1822565-2013-00176
    Event Type
    Injury
    Date Received
    January 24, 2013
    Report Date
    December 27, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34903 NEXGEN CR-FLEX ARTICULAR SURFACE JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NEXGEN STEMMED TIBIAL COMPONENT| CATALOG #00598004702, LOT #61161343| MANUFACTURED AT ZIMMER BV, PONCE, PUERTO RICO| IMPLANTED:| NEXGEN CR-FLEX FEMORAL COMPONENT| CATALOG #00595001601, LOT #60959316| CATALOG #00597206535, LOT #61183202| NEXGEN ALL POLY PATELLA| MANUFACTURED AT ZIMMER BV, PONCE, PUERTO RICO