BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 78532 · Received March 20, 1997

    Report

    Report Number
    78532
    Event Type
    Injury
    Date Received
    March 20, 1997
    Date of Event
    February 20, 1997
    Report Date
    March 18, 1997
    Manufacturer
    UNK
    Product Code
    KXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD A RIGHT ANKLE REPLACEMENT APPROX 10 YEARS AGO. LAST YEAR SHE BEGAN DEVELOPING PAIN AND SWELLING. THE ANKLE IMPLANT WAS REMOVED DURING SURGERY ON 2/20/97. DURING SURGERY IT WAS DISCOVERED THAT THE TALAR COMPONENT ALONG WITH THE POLYETHYLENE COMPONENT WERE LOOSE. THE MEDIAL PART OF THE TALUS WAS TOTALLY DISINTEGRATED AND A LARGE AMOUNT OF METAL DEBRIS AND POLYETHYLENE WEAR WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant UNK KXC UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention