BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN STAGEONE

    MDR report key: 6176607 · Received December 15, 2016

    Report

    Report Number
    0001825034-2016-05193
    Event Type
    Death
    Date Received
    December 15, 2016
    Report Date
    May 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED. THE PRODUCT WAS NOT RETURNED, AND ITS LOCATION IS UNKNOWN. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. PATIENT DATE OF BIRTH/AGE - NI, PATIENT WEIGHT - NI, DATE OF EVENT - NI, DEVICE PRODUCT CODE - NI, EXPIRATION DATE - NI, UNIQUE IDENTIFIER (UDI) # - NI, DATE IMPLANTED - NI, DATE EXPLANTED - NI, (B)(6), MANUFACTURE DATE ¿ NI.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED "THE FATE OF SPACERS IN THE TREATMENT OF PERIPROSTHETIC JOINT INFECTION" WHICH AIMED TO INVESTIGATE THE NATURAL HISTORY OF RESECTION ARTHROPLASTY AND SPACER IMPLANTATION IN PATIENTS UNDERGOING THE FIRST STAGE OF A PLANNED TWO-STAGE EXCHANGE ARTHROPLASTY FOR TREATMENT OF PERIPROSTHETIC JOINT INFECTION, USING THE STAGEONE SYSTEM MANUFACTURED AT BIOMET. IT WAS REPORTED THAT SIXTY-NINE (69) KNEE PATIENTS DIED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829587 UNKNOWN STAGEONE PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death