BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50MM LEFT MAND COMPONENT TI

    MDR report key: 14976420 · Received July 11, 2022

    Report

    Report Number
    0001032347-2022-00219
    Event Type
    Injury
    Date Received
    July 11, 2022
    Date of Event
    October 4, 2021
    Report Date
    October 13, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    N/A
    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 PRODUCTS: ITEM# 24-6561, LOT 014090: TMJ SYSTEM LEFT FOSSA COMPONENT, MEDIUM TI. 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: 0001032347-2022-00218.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D6: IMPLANT DATE: UNKNOWN. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SIGNIFICANT PAST MEDICAL HISTORY INCLUDES: CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ASTHMA, SELECTIVE IMMUNODEFICIENCY, HYPERTENSION, SJOGREN¿S DISEASE, OSTEOARTHRITIS, MVP, LEFT TMJ REPLACEMENT IN 2003. BILATERAL TEMPOROMANDIBULAR JOINT REPLACEMENT WITH TITANIUM DEVICE WAS DONE IN 2021, WHERE THE EXISTING LEFT TEMPOROMANDIBULAR JOINT REPLACEMENT WAS REMOVED. RESECTED BONE FROM CONDYLE AND EXPLANTED TMJ HARDWARE WAS SENT TO MICROBIOLOGY. EXISTING LEFT SIDED TMJ PROSTHESIS WAS BRITTLE. RIGHT TMJ DISC WAS FOUND TO HAVE DEGENERATIVE CHANGES. ON THE LEFT SIDE, AN OBWEGESER PERISTEAL ELEVATOR WAS USED TO DISSECT TISSUE OFF OF THE HEAD OF THE METAL CONDYLAR PROSTHESIS. FOUR SCREWS AND CONDYLAR PROSTHESIS WERE REMOVED. A TROUGH WAS CREATED BETWEEN THE CONDYLAR PROSTHESIS TO REMOVE ANY HETEROTOPIC BONE FORMATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 SECTION B4, B5, D4, D6, G3, G6, H2, H3, H6 AND H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT SIDE TMJ PROCEDURE SEVENTEEN YEARS AGO, AND HAS BEEN REVISED DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT IS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN PRIOR TO THE REVISION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499357 50MM LEFT MAND COMPONENT TI JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 480700

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H