BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR FEMORAL COMPONENT

    MDR report key: 2971865 · Received February 19, 2013

    Report

    Report Number
    1822565-2013-00346
    Event Type
    Injury
    Date Received
    February 19, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ZIMMER MAKES INFO AVAILABLE IN THE PUBLIC DOMAIN RELATED TO THE COMPOSITION OF ZIMMER METAL IMPLANTS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT STATED POSSIBLE ALLERGIC REACTION TO LEFT KNEE IMPLANT. A REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72764 NEXGEN CR FEMORAL COMPONENT MBH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT #UNK.| NEXGEN MIS DROP DOWN STEM: CATALOG #00595006745,