BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB

    MDR report key: 2930442 · Received January 23, 2013

    Report

    Report Number
    9613350-2013-01292
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    July 24, 2012
    Report Date
    January 22, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS WERE NOT RETURNED TO DATE. AS NO LOT NUMBER WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. BESIDE THE FALL OF THE PT SHORTLY AFTER THE PRIMARY SURGERY, A CAUSE FOR THE SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT FELL DOWN AND HAD A PERIPROSTHETIC FEMUR FRACTURE ON THE RIGHT SIDE. SHE UNDERWENT A FIRST SURGERY ON (B)(6) 2012 AND A NCB PLATE WAS IMPLANTED. AFTER A NEW FALL (IN THE STAIRS), THE PT UNDERWENT A REVISION SURGERY ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33163 NCB NCB PLATES HRS ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention