BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER NATURAL NAIL

    MDR report key: 2113552 · Received June 1, 2011

    Report

    Report Number
    1822565-2011-01307
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS REPORT WAS PREVIOUSLY SUBMITTED UNDER THE INCORRECT REGISTRATION SITE VIA REPORT 9613350-2011-00330. EVAL SUMMARY: ACCORDING TO PHYSICIAN ASSISTANT WORKING WITH DR. (B)(6), THE PT WAS REPORTED TO BE NONCOMPLIANT, POSSIBLY RESULTING IN MALUNION, AND AS A RESULT, POSSIBLE FRACTURE OF THE IMPLANTED NAIL. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT REVISION DUE TO BREAKAGE OF THE NAIL. IT IS ALSO REPORTED THAT PT WAS NON-COMPLIANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER NATURAL NAIL TRAUMA PROSTHESIS HSB ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention