BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE

    MDR report key: 10691201 · Received October 16, 2020

    Report

    Report Number
    0001032347-2020-00523
    Event Type
    Injury
    Date Received
    October 16, 2020
    Report Date
    October 5, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    UDI-DI
    00841036060329
    PMA / PMN Number
    P020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. 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

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). 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: 0001032347-2020-00524, 0001032347-2020-00525, 0001032347-2020-00526. EXPLANTATION DATE IS PLANNED FOR (B)(6) 2021. MEDICAL PRODUCTS: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE, PART# 24-6551, LOT# 159860. TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL, PART# 24-6563, LOT# 123880. TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL, PART# 24-6562, LOT# 228220. TMJ SYSTEM RIGHT STANDARD OFFSET MANDIBULAR COMPONENT 50MM / 9 HOLE, PART# 24-6650, LOT# 188200. UNKNOWN SCREWS, PART# NI, LOT# NI. OCCUPATION¿ PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WILL UNDERGO A REVISION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS THIRTEEN (13) YEARS FOLLOWING IMPLANTATION DUE TO HETEROTOPIC BONE GROWTH. THE PATIENT FEELS THAT THE DEVICES HAVE WORKED WELL AND IT IS THE BONY OVERGROWTH THAT CAUSES A LIMITED RANGE OF MOTION. IT IS POSSIBLE THE IMPLANTS WILL BE REPLACED WITH A CUSTOM DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158753 TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 159860 00841036060329

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.