BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB PLATE FOR FEMUR, LEFT, 5 HOLES

    MDR report key: 1972194 · Received January 18, 2011

    Report

    Report Number
    9613350-2011-00041
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    November 20, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES YET, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE REC'D FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. THIS REPORT WILL BE AMENDED ONCE THE PARTS WERE REC'D AND THE INVESTIGATION ACCOMPLISHED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE NCB FEMORAL PLATE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCB PLATE FOR FEMUR, LEFT, 5 HOLES NCB PLATING SYSTEM HRS ZIMMER GMBH 2554467

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization