BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK PRI TIB TRAY 91MM

    MDR report key: 6951984 · Received October 16, 2017

    Report

    Report Number
    0001825034-2017-08701
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    January 22, 2016
    Report Date
    October 13, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM#183686; LOT#710360 - VNGD PS TIB BRG 16X87/91MM, ITEM#183113; LOT#094360 - VAN PS OPEN INTL FEM-RT 72.5. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL COMPLAINTS THAT WERE INVESTIGATED, AND IT WAS DETERMINED THAT NO FURTHER ACTION IS REQUIRED DUE TO THE TIME FRAME OVER WHICH THE PRODUCTS WERE MANUFACTURED. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICES WERE STERILIZED IN ACCORDANCE WITH (B)(4). REQUESTED CONTACT TO VERBALLY RELAY RESULTS TO THE CUSTOMER. DEVICE NOT RETURNED; FDA 92 INCONCLUSIVE-ROOT CAUSE CANNOT BE DETERMINED; KNOWN INHERENT RISK OF PROCEDURE; CONDITION IS ADDRESSED IN PACKAGE INSERT. COMPLETION OF THE INVESTIGATION RELAYED TO AUSTRALIA CONTACT VIA EMAIL ON (B)(6). 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6). SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) DUE TO LOOSENING AND INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACE WITH SPACER MOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732196 BIOMET ILOK PRI TIB TRAY 91MM PROSTHESIS - KNEE MBV ZIMMER BIOMET, INC. NI 006630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R