BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE

    MDR report key: 10112021 · Received June 2, 2020

    Report

    Report Number
    0001032347-2020-00242
    Event Type
    Injury
    Date Received
    June 2, 2020
    Report Date
    November 5, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    UDI-DI
    00841036060343
    PMA / PMN Number
    P020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. NO PRODUCT WAS RETURNED; THEREFORE, NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. THE NON-CONFORMANCE DATABASE WAS REVIEWED FOR THE MANDIBLE COMPONENT; NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THERE HAVE BEEN 5 COMPLAINTS OF PAIN AND 2 COMPLAINTS OF SCAR TISSUE FOR THIS ITEM# 24-6550, LOT# 143380. FOR ALL NON-CUSTOM TMJ MANDIBULAR IMPLANTS IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING PAIN, THERE IS A (B)(4), WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. FOR ALL NON-CUSTOM TMJ MANDIBULAR IMPLANTS IN THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING SCAR TISSUE, THERE IS A (B)(4) WHICH IS NO GREATER THAN THE OCCURRENCE LISTED IN THE APPLICATION FMEA. THE MOST LIKELY UNDERLYING CAUSE 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 DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED; 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: 0001032347-2020-00243, 0001032347-2020-00244, 0001032347-2020-00245, 0001032347-2020-00246, 0001032347-2020-00247, 0001032347-2020-00248. MEDICAL PRODUCTS: TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE, PART# 24-6550, LOT# 143380. TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE, PART# 24-6551, LOT# 164350. TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL, PART# 24-6562, LOT# 328390. TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL, PART# 24-6563, LOT# 212940. 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7MM X 8MM, PART# 91-2708, LOT# UNK. 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7 X 10MM, PART# 91-2710, LOT# UNK. TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 9MM, PART# 99-6579, LOT# UNK. OCCUPATION: PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A SCAR TISSUE REMOVAL PROCEDURE AND CURRENTLY UNDERGOES PAIN MANAGEMENT FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS TWELVE YEARS AGO. THE PATIENT REPORTED A SCAR TISSUE REMOVAL PROCEDURE TWO (2) YEARS AGO. THE PATIENT ATTENDS A PAIN MANAGEMENT CONSULT EVERY SIX (6) TO EIGHT (8) WEEKS. THE PATIENT HAS PREVIOUSLY RECEIVED CORTISONE SHOTS AND IS CURRENTLY ON BOTOX SHOTS, CELEBREX AND OXYCODONE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576502 TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 143380 00841036060343

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R