BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET FINN TIBIAL TRAY

    MDR report key: 6833497 · Received August 31, 2017

    Report

    Report Number
    0001825034-2017-06906
    Event Type
    Injury
    Date Received
    August 31, 2017
    Date of Event
    April 6, 2016
    Report Date
    August 30, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: UNKNOWN BIOMET FINN BEARING, UNKNOWN BIOMET FINN FEMORAL COMPONENT. INITIAL REPORTER: MAURICIO ETCHEBEHERE MD PHD, PATRICK P. LIN MD, JUSTIN E BIRD MD, ROBERT L SATCHER, MD, PHD, BRYAN S. MOON, JUN YU, LIANG LI AND VALARAE O. LEWIS ¿PATELLAR RESURFACING¿ THE JOURNAL OF BONE & JOINT SURGERY D JBJ S .ORG VOLUME 98-A D NUMBER 7 D APRIL 6, 2016 INVOLVING HOSPITALS THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER, HOUSTON, TEXAS AND STATE UNIVERSITY OF CAMPINAS, SAO PAULO, BRAZIL. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06904, 0001825034-2017-06905.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FIVE (5) PATIENTS WHO DID NOT HAVE THEIR PATELLA RESURFACED EXPERIENCED ARTHROFIBROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615207 UNKNOWN BIOMET FINN TIBIAL TRAY PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other