BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB PLATE FOR FEMUR, RIGHT, 13 HOLES

    MDR report key: 1233865 · Received November 13, 2008

    Report

    Report Number
    9613350-2008-00212
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 13, 2008
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008, PATIENT WAS OPERATED WITH ANOTHER NCB DF BECAUSE OF A FRACTURE. TWO MONTHS LATER, THE PATIENT HAD INCREASED PAIN AND X-RAYS SHOWED THAT THE SCREWS HAD LOOSENED AND THAT THE PLATE WAS TOO SHORT. THEY THEN DECIDED TO CHANGE TO A LONGER PLATE. EVERYTHING WAS FINE AND ON THE X-RAYS, TWO MONTHS LATER, SHOWED NO CALLUS FORMATION. AFTER THAT THE PATIENT WAS PERMITTED TO LOAD. THE FOLLOWING MONTH, THE PATIENT CALLED THE HOSPITAL BECAUSE SHE EXPERIENCED PAIN IN HER LEG AGAIN. ANOTHER X-RAY SHOWED A PLATE BREAKAGE. THE SURGEON THEN DECIDED TO CHANGE THE PLATE TO A SYNTHES LCP 13 HOLE TO BE ABLE TO PLACE THE SCREWS IN NEW BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCB PLATE FOR FEMUR, RIGHT, 13 HOLES NCB PLATING SYSTEM HRS ZIMMER GMBH 08348302

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R