BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER KNEE

    MDR report key: 3022470 · Received March 20, 2013

    Report

    Report Number
    1822565-2013-00507
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVALUATION CODES: 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 IS EXPERIENCING LEFT KNEE CLICKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115536 UNK ZIMMER KNEE KNEE PROSTHESIS HRZ ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other