BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX BIOMET PRIMARY TIBIAL TRAY WITH LOCKING BAR

    MDR report key: 6796800 · Received August 16, 2017

    Report

    Report Number
    0001825034-2017-06341
    Event Type
    Injury
    Date Received
    August 16, 2017
    Report Date
    October 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK080361
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: CATALOG #: 141358, REGENEREX POROUS TITANIUM PATELLA 3 PEG, LOT # 342960. CATALOG #: 141314, MAXIM BIOMET KNEE SYSTEM MODULAR FINNED STEM WITH SCREW, LOT # 125820. CATALOG #: EP-183560, VANGUARD KNEE SYSTEM LIPPED TIBIAL BEARING, LOT # 773760. CATALOG #: 183054, VANGUARD KNEE SYSTEM FEMORAL POROUS PLASMA RIGHT, LOT # 176910. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, BECAUSE IT IS STILL IMPLANTED IN THE PATIENT. 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: 0001825034-2017-06336, 06337, 06338, AND 06340. DEVICE RETAINED BY FACILITY.

    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 WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. 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 PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY EXPERIENCED PAIN FROM DAY ONE. THE PATIENT ALSO EXPERIENCED SWELLING AND LIMITED RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577031 REGENEREX BIOMET PRIMARY TIBIAL TRAY WITH LOCKING BAR PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 977200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other