BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK PRI TIB TRAY 59MM

    MDR report key: 9539097 · Received January 2, 2020

    Report

    Report Number
    0001825034-2020-00013
    Event Type
    Injury
    Date Received
    January 2, 2020
    Date of Event
    December 4, 2019
    Report Date
    April 3, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K915132
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND THE REPORTED EVENT WAS CONFIRMED THROUGH PICTURES AND MEDICAL RECORDS. PICTURES OF THE EXPLANTED DEVICES SHOWED A PIECE OF THE TIBIAL TRAY HAD FRACTURED OFF AND THE BEARING WAS EXTREMELY WORN. METALLOSIS WAS ALSO NOTED IN THE JOINT SPACE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 183400, TIBIAL BEARING, LOT # 421320, UNKNOWN FEMORAL COMPONENT. REPORT SOURCE: EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 00012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 9 YEARS POST IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN AND A FEELING OF INSTABILITY WITH THE RIGHT KNEE. SUBSEQUENTLY, AT 10 YEARS POST OP, THE PATIENT WAS SEEN BY PHYSICIAN AND FOUND TO HAVE LARGE VARUS. SURGEON SUSPECTED IMMINENT FRACTURE OF IMPLANT, AND PERFORMED A REVISION DUE TO INSTABILITY AND METALLOSIS WAS ALSO OBSERVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581 BIOMET ILOK PRI TIB TRAY 59MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 716390

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R SEE H10