BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN CMN NAIL 10MMX21.5CM 125R

    MDR report key: 2070286 · Received April 15, 2011

    Report

    Report Number
    9613350-2011-00230
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER AUSTRALIA., WHICH MARKETS THE DEVICES IN (B)(4). THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS, THEREFORE, NOT SUSPECTED THAT DEVICE FAILURE LEAD TO THE ALLEGED EVENT. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADD'L INFO 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 FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER GMBH CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT REVISION SURGERY DUE TO BREAKAGE OF THE NAIL. THE RETRIEVAL WILL NOT BE AVAILABLE FOR INVESTIGATION. THIS PT IS PARTICIPATING IN A (B)(4) STUDY ON ZIMMER NATURAL NAIL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZNN CMN NAIL 10MMX21.5CM 125R ZIMMER NATURAL NAIL SYSTEM JDS ZIMMER GMBH 2557716

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O