BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NP FEM LT SZ3 NK II

    MDR report key: 516043 · Received March 16, 2004

    Report

    Report Number
    2935620-2004-00023
    Event Type
    Injury
    Date Received
    March 16, 2004
    Date of Event
    December 8, 2003
    Report Date
    March 16, 2004
    Manufacturer
    CENTERPULSE ORTHOPEDICS, INC.
    Product Code
    HSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD AN ABOVE KNEE AMPUTATION IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NP FEM LT SZ3 NK II KNEE PROSTHESIS HSA CENTERPULSE ORTHOPEDICS, INC. NA 1571685

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Disability NKII DUR. POLY PATELLA SZ2 10MM LOT#1555014, 2003.| NKII DUR U/CONG TIB INS SZ2 LT 16MM LOT#1477712,03| NP STM B/P LT SZ2 NKII LOT# 1582775 2003.