BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UKNOWN ZIMMER INTERNAL FIXATION DEVICE

    MDR report key: 2023260 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00629
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED THROUGH A JOURNAL ARTICLE THAT IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: THE INFO PROVIDED IS NOT SUFFICIENT TO MAKE AN APPROPRIATE DETERMINATION ON THE FAILURE. 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 REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT UNDERWENT MANIPULATION UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UKNOWN ZIMMER INTERNAL FIXATION DEVICE TRAUMA PROSTHESIS KTT ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention