BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE

    MDR report key: 516128 · Received March 4, 2004

    Report

    Report Number
    MW1031436
    Event Type
    Injury
    Date Received
    March 4, 2004
    Date of Event
    August 26, 2003
    Report Date
    March 4, 2004
    Manufacturer
    *
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 6/9/04: BASED ON THE INFO IN THE MEDICAL DEVICE REPORT, THE MODEL NUMBER WAS 120-01-032 OR 120-01-029, THESE ARE THE TWO SIZES OF PATELLAR PROSTHESIS FOR THE ENCORE FOUNDATION KNEE SYSTEM. MODEL NUMBER 120-01-032, LOT NUMBER 874271. MODEL NUMBER 120-01-029, LOT NUMBER 884221. ENCORE SUBMITTED MEDWATCH REPORT NUMBER 1644408-2003-00068 FOR THE ENCORE FOUNDATION KNEE SYSTEM. DEVICES 120-01-029 AND 120-01-032 ARE COMPONENTS OF THAT SYSTEM.

    Description of Event or Problem · 1

    TOTAL KNEE REPLACEMENT DONE USING THE ENCORE KNEE PRODUCT. HAD TO BE REPLACED IN EARLY 2003 AND HAD NUMEROUS SURGERIES SINCE THEN. SUSPICION IS THAT PRODUCT HAD CONTAMINATION. OF THE 13 CASES PHYSICIAN DID AROUND THAT TIME FRAME 10 HAD TO BE REPLACED BY JAN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE KNEE REPLACEMENT PRODUCT HTG * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R