BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM LEFT NARROW MANIBULAR COMPONENT

    MDR report key: 7614927 · Received June 19, 2018

    Report

    Report Number
    0001032347-2018-00386
    Event Type
    Injury
    Date Received
    June 19, 2018
    Report Date
    November 30, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS A REVISION INVOLVING THESE PARTS: THE COMPLAINT IS CONSIDERED CONFIRMED. NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. IT WAS NOT CLEAR WHAT CAUSED THE PATIENT'S REACTION, THEREFORE THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT WARNS OF THE POTENTIAL FOR COMPLICATIONS. IT STATES IN THE SECTION TITLED ADVERSE EVENTS: INFECTION (SYSTEMIC OR SUPERFICIAL) THE IFU ALSO STATES IN THE SECTION TITLED PATIENT COUNSELING INFORMATION: DISCUSSION OF THE FOLLOWING POINTS IS RECOMMENDED PRIOR TO SURGERY. THE IMPORTANCE OF PROMPT MEDICAL ATTENTION IF THEY EXPERIENCE UNUSUAL SWELLING IN THE AREA OF THE IMPLANT. THE RISKS ASSOCIATED WITH A TOTAL TMJ SYSTEM (SEE WARNINGS AND ADVERSE EVENTS). POST-OPERATIVE PAIN RELIEF AND RETURN OF FUNCTION VARIES FROM PATIENT TO PATIENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE FOSSA COMPONENT AND NO DISCREPANCIES WERE FOUND. DHR WAS REVIEWED FOR THE MANDIBULAR COMPONENT AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. DHR REVIEW WAS UNABLE TO BE PERFORMED FOR THE SCREWS AS THE LOT NUMBERS OF THE DEVICES INVOLVED IN THE EVENT ARE UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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: 0001032347-2018-00385-1, 0001032347-2018-00387-1, 0001032347-2018-00388-1, AND 0001032347-2018-00389-1.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL CATALOG # 24-6563 LOT #: 648680B, BIOMET MICROFIXATION "2.4 MM" SYSTEM HT CROSS-DRIVE SCREW CATALOG #: 91-2710 LOT #: NI, BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW CATALOG #: 99-6577 LOT #: NI, BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW CATALOG #: 99-6579 LOT #: NI. THERAPY DATE: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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: 0001032347-2018-00385, 0001032347-2018-00387, 0001032347-2018-00388, AND 0001032347-2018-00389.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURGEON DURING FOLLOW UP ON THE PATIENT'S REVISION CASE THAT AN EXPLORATORY SURGERY WAS PERFORMED PREVIOUSLY, IN WHICH HE SURGEON CLEANED AND IRRIGATED THE JOINT AND HE HAD NOTICED SOME SORT OF BIOFILM/PUS. THE DATE OF THE SURGERY IS UNKNOWN. THE SURGEON STATED THE JOINT WAS EXPLANTED SOMETIME IN (B)(6) OR (B)(6) 2018; SEE ASSOCIATED REPORTS 0001032347-2018-00294, 0001032347-2018-00295, 0001032347-2018-00296, 0001032347-2018-00297, AND 0001032347-2018-00298.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458542 TMJ SYSTEM LEFT NARROW MANIBULAR COMPONENT JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 589730A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R