BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK NEXGEN KNEE IMPLANT

    MDR report key: 2921456 · Received January 9, 2013

    Report

    Report Number
    1822565-2013-00043
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 11, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY - NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. NEITHER SURGICAL NOTES NOR X-RAYS WERE PROVIDED, THEREFORE FIT AND ORIENTATION COULD NOT BE EVALUATED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. 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 WAS REPORTED THAT THE PT IS ALLEGING HARM CAUSED BY THE DEVICE; HOWEVER, THE NATURE OF THE HARM IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12614 UNK NEXGEN KNEE IMPLANT KNEE PROSTHESIS MBH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other