BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEMMED TIBIAL COMPONENT PRECOAT SIZE 3

    MDR report key: 8211164 · Received January 2, 2019

    Report

    Report Number
    0002648920-2019-00007
    Event Type
    Death
    Date Received
    January 2, 2019
    Date of Event
    November 7, 2012
    Report Date
    January 14, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    K933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00576401552 FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE E RIGHT 61538463, 00597206532 ALL POLY PATELLA SIZE 32 MM DIA. STANDARD 8.5 MM THICKNESS 61612169, 00596203210 NG LPS-FLEX FIXED PROLONG ART SURF, 10MM 61631571. THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3007963827 - 2019 - 00003, 0001822565 - 2017 - 08353, 0001822565 - 2017 - 08291.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.  REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT LEGAL COUNSEL THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY AND WAS SUBSEQUENTLY REVISED DUE TO PAIN APPROXIMATELY TWO YEARS POST IMPLANTATION. NO ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3797 STEMMED TIBIAL COMPONENT PRECOAT SIZE 3 PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. N/A 61603707

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R