BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TMJ LEFT FOSSA

    MDR report key: 21304228 · Received February 4, 2025

    Report

    Report Number
    0001032347-2025-00057
    Event Type
    Injury
    Date Received
    February 4, 2025
    Report Date
    June 2, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MFR#0001032347-2025-00023. THIS EVENT WILL CONTINUE TO BE REPORTED ON THIS MFR #0001032347-2025-00057. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, G3, G6, H2, H3, H10 AND H11.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D6A - IMPLANT DATE - UNKNOWN DATE IN (B)(6) 2011. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. 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. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, G3, G6, H2, H3, H6, H10, AND H11.

    Additional Manufacturer Narrative · 0

    D6: IMPLANT DATE: UNKNOWN DATE IN 2011. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, D6, G3, G6, H2, H6, AND H11.

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). D10: MEDICAL PRODUCTS. ITEM #UNK, LOT #UNK; UNKNOWN. TMJ LEFT MANDIBLE COMPONENT. ITEM #UNK, LOT #UNK; UNKNOWN. TMJ LEFT FOSSA COMPONENT. ITEM #UNK, LOT #UNK; UNKNOWN TMJ RIGHT MANDIBLE COMPONENT. ITEM #UNK, LOT #UNK; UNKNOWN MTJ RIGHT FOSSA COMPONENT. G2: FOREIGN: UNITED KINGDOM. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT IS FURTHER REPORTED THAT THE FUTURE REVISION IS DUE TO THE IMPLANTS BEING TOO CLOSE TO THE EAR CANAL AND THIS IS SUSPECTED AS CAUSE OF PAIN FOR PATIENT. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENT UNDERWENT A BILATERAL TMJ PROCEDURE ON AN UNKNOWN DATE; SUBSEQUENTLY, THE PATIENT IS BEING PLANNED FOR A REVISION TO A CUSTOM TMJ SYSTEM DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134517 UNK TMJ LEFT FOSSA JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11