BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL

    MDR report key: 7031948 · Received November 14, 2017

    Report

    Report Number
    0001032347-2017-00804
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    September 18, 2017
    Report Date
    October 18, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. PRODUCT WAS RETURNED IN BIOHAZARDOUS CONDITION. VISUAL INSPECTION SHOW NORMAL WEAR AND TEAR ASSOCIATED WITH THE IMPLANTATION AND REMOVAL OF THESE PRODUCTS. THERE ARE NO SIGN OF DEFECTS ON ANY OF THE PRODUCTS. THERE WAS NO ALLEGED MALFUNCTION OF THE IMPLANT. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT CONDITION. 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. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT STATES IN THE SECTION TITLED ADVERSE EVENTS: ADVERSE EVENTS THAT MAY OCCUR FOLLOWING PLACEMENT OF THE TOTAL TMJ REPLACEMENT SYSTEM ARE LISTED BELOW. ¿ HETEROTOPIC BONE FORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00142-2, 0001032347-2018-00304-1, AND 0001032347-2018-00305-1.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). MEDICAL PRODUCT: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT CATALOG #: 24-6556TI LOT #: 283260, BIOMET MICROFIXATION "2.4MM" SYSTEM HT CROSS-DRIVE SCREW CATALOG #: 91-2710 LOT #: NI, BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW CATALOG #: 99-6577 LOT #: NI. THERAPY DATE: (B)(6) 2017. REPORT SOURCE: FOREIGN COUNTRY - (B)(6). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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: 0001032347-2018-00142-1, 0001032347-2018-00304, AND 0001032347-2018-00305.

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. BECAUSE THE PART AND LOT NUMBERS ARE UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. NO PRODUCT WAS RETURNED AND NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REMOVAL OF THE TEMPORMANDIBULAR JOINT (TMJ) PROSTHESIS WAS PERFORMED DUE TO THE PATIENT'S HETEROTOPIC BONE FORMATION AND ANKYLOSIS. MORE INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806688 TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R