BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL

    MDR report key: 7379424 · Received March 28, 2018

    Report

    Report Number
    0001032347-2018-00155
    Event Type
    Injury
    Date Received
    March 28, 2018
    Report Date
    August 30, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE PATIENT REPORTS PAIN, BUT IS NOT CURRENTLY TAKING ANY MEDICATION. THE PRODUCTS REMAIN IMPLANTED, THEREFORE, VISUAL EVALUATION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THERE WERE NO PHOTOGRAPHS, X-RAYS, CT SCANS, OR PHYSICIAN'S REPORTS PROVIDED TO SUBSTANTIATE THE COMPLAINT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT HAS THE FOLLOWING INFORMATION IN THE SECTION TITLED ADVERSE EVENTS: FACIAL SWELLING AND/OR PAIN. 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: 0001032347-2018-00152-1, 0001032347-2018-00153-1, AND 0001032347-2018-00154-1.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). DMEDICAL PRODUCT: BIOMET MICROFIXATION TMJ RIGHT NARROW MANDIBULAR COMPONENT CATALOG #: 01-6545 LOT #: 589010D, BIOMET MICROFIXATION TMJ LEFT NARROW MANDIBULAR COMPONENT CATALOG #: 01-6551 LOT #: 472530B BIOMET MICROFIXATION TMJ RIGHT FOSSA COMPONENT, SMALL CATALOG #: 24-6562 LOT #: 625150B, UNKNOWN SCREWS. THERAPY DATE: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, THE JOINTS REMAIN 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: 0001032347-2018-00152, 0001032347-2018-00153, AND 0001032347-2018-00154.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE¿S STILL IN PAIN, BUT THAT THE IMPLANTS WERE LIFE CHANGING AND SHE¿S SO THANKFUL FOR THEM. SHE STATES SHE IS EXPERIENCING MUSCULAR PAIN, NOT FROM HER JOINT. SHE HAD BEEN RECEIVING BOTOX INJECTIONS EVERY THREE MONTHS. THE PLAN WAS TO ADMINISTER THE BOTOX INJECTIONS UNTIL HER "MUSCLE MEMORY FORGETS THE PAIN." HOWEVER, HER INSURANCE STOPPED COVERING IT AND SHE COULDN'T AFFORD TO CONTINUE TREATMENT. SHE STATED SHE HAD DOUBLE JAW SURGERIES IN THE PAST AND, THOUGH PRESCRIBED MEDICATION, SHE DID NOT TAKE ANY AS SHE HAS A VERY HIGH PAIN TOLERANCE. SHE IS NOT CURRENTLY TAKING ANY MEDICATION IN LIEU OF THE BOTOX INJECTIONS. SHE STATES THE BOTOX INJECTIONS DID HELP A LOT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220866 TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 650160A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention