BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT

    MDR report key: 15146205 · Received August 2, 2022

    Report

    Report Number
    0001032347-2022-00239
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    May 12, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). MEDICAL PRODUCT - ZIMMER BIOMET TMJ SYSTEM MEDIUM RIGHT FOSSA COMPONENT CATALOG #: 24-6560 LOT #: 853110, ZIMMER BIOMET TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT CATALOG #: 24-6545 LOT #: 897790, AND ZIMMER BIOMET TMJ SYSTEM MEDIUM LEFT FOSSA COMPONENT CATALOG #: 24-6561 LOT #: 853120. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; 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: 0001032347-2022-00238, 0001032347-2022-00240, AND 0001032347-2022-00241.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; B6; G3; G6; H1; H2; H3; H6; H10.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL TMJ REPLACEMENT PROCEDURE APPROXIMATELY SIXTEEN (16) YEARS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO AN UNKNOWN REASON APPROXIMATELY THREE (3) MONTHS AGO. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TMJ REVISION SURGERY DUE TO SIGNIFICANT TRISMUS AND HETEROTOPIC BONE FORMATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063975 TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 897800

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE