BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZNN CMN NAIL 10MMX34CM 130 L

    MDR report key: 3202130 · Received June 18, 2013

    Report

    Report Number
    9613350-2013-01647
    Event Type
    Other
    Date Received
    June 18, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PT IS MONITORED AND HAS NOT BEEN REVISED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A FALL ON (B)(6) 2013. THE SAME DAY, THE PT UNDERWENT SURGERY AND WAS IMPLANTED WITH A ZNN CMN NAIL 10 MM X 34 CM 130 L WITH CERCLAGE. THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013, AND WAS SENT TO A NURSING HOME. THE PT IS IN A WHEELCHAIR AND IS ONLY ABLE TO WALK A FEW STEPS WITH THE HELP OF A MOBILE WALKING FRAME. ON (B)(6) 2013, THE PT EXPERIENCED PAIN. DUE TO PROGRESSION OF PAIN WITHOUT TRAUMA, THE PT WAS RE-HOSPITALIZED ON (B)(6) 2013, AND A PLAN OF REVISION SURGERY HAS BEEN DISCUSSED. THE DATE OF THE PLANNED SURGERY HAS NOT BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275396 ZNN CMN NAIL 10MMX34CM 130 L ZNN, INTRASYS NAIL, CEPHALOMEDULLARY NAIL HSB ZIMMER, INC. 2676629

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other