BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ MEDIUM LEFT FOSSA COMPONENT

    MDR report key: 18730760 · Received February 19, 2024

    Report

    Report Number
    0001032347-2024-00059
    Event Type
    Injury
    Date Received
    February 19, 2024
    Report Date
    April 16, 2024
    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). D10: MEDICAL PRODUCT - ZIMMER BIOMET TMJ MEDIUM LEFT FOSSA COMPONENT CATALOG #: 24-6561 LOT #: 360310; ZIMMER BIOMET TMJ MEDIUM RIGHT FOSSA COMPONENT CATALOG #: 24-6560 LOT #: 360330; ZIMMER BIOMET RIGHT STANDARD MANDIBULAR COMPONENT CATALOG #: 24-6545 LOT #: 123440; ZIMMER BIOMET LEFT STANDARD MANDIBULAR COMPONENT CATALOG #: 24-6546 LOT #: 123450. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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: 0001032347-2024-00060, 0001032347-2024-00061, AND 0001032347-2024-00062.

    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 IS EXPERIENCING A HIGH LEVEL OF PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    495253 TMJ MEDIUM LEFT FOSSA COMPONENT JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 360310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other