BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL

    MDR report key: 9677230 · Received February 6, 2020

    Report

    Report Number
    0001032347-2020-00091
    Event Type
    Injury
    Date Received
    February 6, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    UDI-DI
    00841036036584
    PMA / PMN Number
    P020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED AS A REVISION SURGERY WAS REPORTED TO ADDRESS THE BONE OVERGROWTH AND DISLOCATION. NO PRODUCT WAS RETURNED; THEREFORE, NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE CONDUCTED. NO SCANS OR PHYSICIAN'S REPORTS WERE PROVIDED. THE NON-CONFORMANCE DATABASE WAS REVIEWED FOR THE FOSSA COMPONENT; NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THERE WERE 5 COMPLAINTS FOR THIS PART# 24-6563, LOT# 190720, INCLUDING THIS COMPLAINT. THREE WERE PREVIOUS COMPLAINTS FROM THE SAME PATIENT. THE LAST COMPLAINT ON THIS LOT# WAS FOR FOSSA REPLACEMENTS DUE TO BONE GROWTH. FOR ALL NON-CUSTOM TMJ FOSSA IMPLANTS IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING PAIN LEADING TO A REVISION SURGERY, THERE IS A COMPLAINT RATE OF 0.47%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE AFMEA. FOR ALL NON-CUSTOM TMJ FOSSA IMPLANTS IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING DISLOCATION, THERE IS A COMPLAINT RATE OF 0.47%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE AFMEA. FOR ALL NON-CUSTOM TMJ FOSSA IMPLANTS IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING LIMITED RANGE OF MOTION LEADING TO A REVISION, THERE IS A COMPLAINT RATE OF 0.10%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE AFMEA. FOR ALL NON-CUSTOM TMJ FOSSA IMPLANTS IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING BONE GROWTH, THERE IS A COMPLAINT RATE OF 0.36%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE AFMEA. FOR ALL NON-CUSTOM TMJ FOSSA IMPLANTS IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING INFECTION, THERE IS A COMPLAINT RATE OF 0.36%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE AFMEA. FOR ALL NON-CUSTOM TMJ FOSSA IMPLANTS IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING ALLERGIC REACTION, THERE IS A COMPLAINT RATE OF 0.47%, WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE AFMEA. THE MOST LIKELY UNDERLYING CAUSE OF THE BONE GROWTH IS DUE TO PATIENT CONDITION. IT WAS REPORTED THAT THIS BONE GROWTH WAS THE CAUSE OF THE DISLOCATION. IT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED IF THE LIMITED RANGE OF MOTION AND PAIN WERE RELATED TO THE BONE GROWTH AND DISLOCATION, OR IF THEY WERE SEPARATE ISSUES. THE ROOT CAUSES OF THE REPORTED POSSIBLE ALLERGIC REACTION TO TITANIUM AND INFECTION COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00088, 0001032347-2020-00089, 0001032347-2020-00090, 0001032347-2020-00092, 0001032347-2020-00093, 0001032347-2020-00094, 0001032347-2020-00095. MEDICAL PRODUCTS: TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT, PART# 24-6545, LOT# 183570, TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT, PART# 24-6546, LOT# 174120, TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL, PART# 24-6562, LOT# 216350, TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL, PART# 24-6563, LOT# 190720, 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, PART# 91-2708, LOT# UNK, 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, PART# 91-2710, LOT# UNK, TMJ SYSTEM CROSS DRIVE FOSSA SCREW, PART# 99-6579, LOT# UNK, TMJ SYSTEM CROSS DRIVE FOSSA SCREW, PART# 99-6581, LOT# UNK. OCCUPATION: PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY DUE TO HETEROTOPIC BONE GROWTH AND DISLOCATION INVOLVING BILATERAL TEMPOROMANDIBULAR JOINT PROSTHESES. THE PATIENT WAS RECEIVED STOCK IMPLANTS OVER A DECADE AGO, AND CURRENTLY REPORTS LIMITED RANGE OF MOTION, HEADACHES, PAIN AND SWELLING. FIFTEEN MONTHS AGO, THE PATIENT REPORTED HETEROTOPIC OSSIFICATION IN THE JOINT AND IMPLANT DISLOCATION ON THE RIGHT SIDE. THIRTEEN MONTHS AGO, THE PATIENT REPORTED A REVISION SURGERY IN WHICH THE EXISTING IMPLANTS WERE RE-POSITIONED. TRIGGER POINT INJECTIONS AND NERVE BLOCKS HAVE BEEN INADEQUATE REGARDING PAIN MANAGEMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139596 TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 190720 00841036036584

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S