BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL

    MDR report key: 8679537 · Received June 7, 2019

    Report

    Report Number
    0001032347-2019-00315
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    February 11, 2019
    Report Date
    August 16, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    UDI-DI
    00841036036560
    PMA / PMN Number
    P020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. SINCE THERE WAS A REVISION TO REMOVE AND REPLACE THESE PARTS, THE COMPLAINT IS CONFIRMED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. 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 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). CONCOMITANT MEDICAL PRODUCTS: ZIMMER BIOMET TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT, CATALOG # : 24-6545, LOT #: 190800; ZIMMER BIOMET TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT, CATALOG #: 24-6546, LOT #: 143340; ZIMMER BIOMET TMJ SYSTEM LEFT FOSSA COMPONENT, MEDIUM, CATALOG #: 24-6561, LOT #: 071560; UNKNOWN SCREWS, CATALOG#: NI, LOT#: NI. 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: 0001032347-2019-00312, 0001032347-2019-00313, 0001032347-2019-00314.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED IN WHICH THE TMJ IMPLANTS WERE REMOVED AND REPLACED WITH NEW IMPLANTS ELEVEN YEARS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471619 TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 284560 00841036036560

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R