BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX TIBIAL COMPONENTS

    MDR report key: 6676314 · Received June 29, 2017

    Report

    Report Number
    0001825034-2017-04447
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    August 24, 2015
    Report Date
    September 30, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK080361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): - REGENEREX 34MM PATELLA, CATALOG 141357, LOT 344230; VANGUARD TIBIAL BEARING 63/67 X 12, CATALOG EP-183522, LOT 911000; VANGUARD FEMUR RIGHT 60MM, CATALOG 183044, LOT 386610; MODULAR SPLINED STEM 40MM, CATALOG 141369, LOT 454860. CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1822565-2017-03198, 1825034-2017-04449, 1825034-2017-04446, 1825034-2017-04447, AND 1825034-2017-04448.

    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. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REVISION APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457159 REGENEREX TIBIAL COMPONENTS PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS 299140

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R