BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT

    MDR report key: 8319699 · Received February 8, 2019

    Report

    Report Number
    0001032347-2019-00090
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    January 8, 2019
    Report Date
    March 19, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCTS WERE EXPLANTED IN A REVISION SURGERY, THEREFORE THE COMPLAINT IS CONSIDERED 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 REVISION SURGERY WAS DUE TO HETEROTOPIC BONE GROWTH, INDICATING THERE WAS NO ALLEGED MALFUNCTION OF THE IMPLANTS. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT WARNS OF THE POTENTIAL FOR COMPLICATIONS. IT STATES IN THE SECTION TITLED ADVERSE EVENTS: ¿ HETEROTOPIC BONE FORMATION THE IFU ALSO STATES IN THE SECTION TITLED PATIENT COUNSELING INFORMATION: DISCUSSION OF THE FOLLOWING POINTS IS RECOMMENDED PRIOR TO SURGERY. ¿ THE RISKS ASSOCIATED WITH A TOTAL TMJ SYSTEM (SEE WARNINGS AND ADVERSE EVENTS). ¿ ADDITIONAL TREATMENT MAY BE REQUIRED INCLUDING BUT NOT LIMITED TO EXTENDED PHYSICAL THERAPY, BITE SPLINT, DENTAL BRACES, AND/OR ORTHOGNATHIC AND RECONSTRUCTIVE SURGERY. THE IFU ALSO INCLUDES STATISTICS FROM CLINICAL STUDIES IN REGARDS TO HETEROTOPIC BONE GROWTH. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBERS OF THE DEVICES INVOLVED IN THE EVENT ARE UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING SECTIONS WERE UPDATED: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00810-2, 0001032347-2019-00088-1, AND 0001032347-2019-00089-1.

    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). (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL CATALOG #: 24-6563 LOT #: NI, BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT CATALOG #: 24-6556 LOT #: NI, BIOMET MICROFIXATION TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL CATALOG #: 24-6562 LOT #: NI, BIOMET MICROFIXATION UNKNOWN SCREWS CATALOG #: NI LOT #: NI. THERAPY DATE: (B)(6) 2019. FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, THE HOSPITAL DOES NOT WISH TO RETURN THEM. 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: 0001032347-2018-00810, 0001032347-2019-00088, AND 0001032347-2019-00089.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION WAS PERFORMED DUE TO THE GROWTH OF HETEROTOPIC BONE. THE EXPLANTED JOINTS WERE IN PERFECT CONDITION. A CUSTOM JOINT WAS IMPLANTED TO REPLACE THE STOCK JOINTS THAT WERE EXPLANTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116995 TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R