BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZNN CMN NAIL 11.5MMX21.5CM 125R

    MDR report key: 2516873 · Received March 29, 2012

    Report

    Report Number
    9613350-2012-00379
    Event Type
    Death
    Date Received
    March 29, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 21, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT YET RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE REC'D FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WITH THE INFO GIVEN SO FAR, NO FURTHER INVESTIGATION IS POSSIBLE. THE ROOT CAUSE FOR THIS EVENT CANNOT BE IDENTIFIED. SHOULD ADD'L INFO INCLUDING THE FINAL INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AND AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT IMPLANTATION TOOK PLACE IN (B)(6) 2011 AND BREAKAGE OF THE PRODUCT OCCURRED ON (B)(6) 2012. REVISION SURGERY WAS PERFORMED ON (B)(6) 2012. DEATH OF THE PT IN THE NIGHT AFTER THE SURGERY. THE PT HAD HAVE CARDIOVASCULARE ANTECEDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZNN CMN NAIL 11.5MMX21.5CM 125R ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDU HSB ZIMMER GMBH 2604080

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death