BEUDAMED
    FDA Adverse Event Other Summary report: N

    NKII DURASUL U/CONG TIB INS SZ 00/0, LT, 13MM

    MDR report key: 370771 · Received January 10, 2002

    Report

    Report Number
    2935620-2001-01836
    Event Type
    Other
    Date Received
    January 10, 2002
    Date of Event
    December 12, 2001
    Report Date
    December 27, 2001
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: PRODUCT WOULD NOT SEAT IN TIBIAL BASEPLATE. SURGEON USED PROPER PROCEDURE WITH GREAT EXPOSURE AND TIBIAL INSERT DID NOT WANT TO SEAT IN THE TIBIAL BASEPLATE. THIS CAUSED A SURGICAL DELAY OF 30 MINUTES. A BACKUP TIBIAL INSERT WAS SEATED WITH NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NKII DURASUL U/CONG TIB INS SZ 00/0, LT, 13MM KNEE PROSTHESIS JWH SULZER ORTHOPEDICS, INC. NA 1483004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization