BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER TRAUMA IMPLANT

    MDR report key: 2921511 · Received January 10, 2013

    Report

    Report Number
    1822565-2013-00075
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 13, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: NO OPERATIVE NOTES, X-RAYS, OR PT INFO WAS CONTAINED WITHIN THE COMPLAINT. CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 SPECIFICATIONS. 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 ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO THE DEVICE BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15468 UNKNOWN ZIMMER TRAUMA IMPLANT TRAUMA PROSTHESIS HSB ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention