BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER ROTATING HING KNEE

    MDR report key: 4147218 · Received October 2, 2014

    Report

    Report Number
    1822565-2014-01291
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    August 13, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING THE REVISION SURGERY, IT WAS NOTED THAT THE COUPLING PIN HAD DISLOCATED AND THE THREADING OF THE PIN SHOWS SIGNS OF WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614312 UNK ZIMMER ROTATING HING KNEE KNEE PROSTHESIS HRZ ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention