BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET REGENEREX TIBIAL COMPONENTS

    MDR report key: 6709878 · Received July 13, 2017

    Report

    Report Number
    0001825034-2017-04889
    Event Type
    Injury
    Date Received
    July 13, 2017
    Report Date
    September 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK080361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT PRODUCTS: BIOMET MCK MAXIMUM CONGRUENT KNEE, CAT#: 141314 LOT#: 104580; BIOMET VANGUARD COMPLETE KNEE SYSTEM, CAT#: 183044 LOT#: 802440; BIOMET VANGUARD COMPLETE KNEE SYSTEM, CAT#: 183420 LOT#: 199130; BIOMET VANGUARD PATELLA COMPONENTS, CAT#: 184762 LOT# 549890. PRODUCT IS CURRENTLY NOT EXPECTED TO RETURN TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. 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: 0001825034-2017-04864, 0001825034-2017-04866, 0001825034-2017-04867, 0001825034-2017-04874, 0001825034-2017-04889.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING A FEVER, PAIN AND SWELLING IMMEDIATELY FOLLOWING A KNEE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491970 BIOMET REGENEREX TIBIAL COMPONENTS PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS 127720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other