BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS UNIVATION XF

    MDR report key: 6683856 · Received July 3, 2017

    Report

    Report Number
    6683856
    Event Type
    Malfunction
    Date Received
    July 3, 2017
    Date of Event
    December 22, 2016
    Report Date
    June 15, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WHO UNDERWENT, LAST FALL, A UNICONDYLAR KNEE ARTHROPLASTY. SHE DEVELOPED PAIN POSTOPERATIVELY AND IT WAS NOTED ON POSTOPERATIVE FILM APPROXIMATELY 6 WEEKS POST-OP THAT THE TIBIA COMPONENT HAD LOOSENED. REQUIRED REMOVAL AND TOTAL KNEE REPLACEMENT (TKR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465179 AS UNIVATION XF PROSTHESIS, KNEE, FEMOROTIBIAL JWH AESCULAP IMPLANT SYSTEMS, LLC NO181Z

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NO