BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45MM RT STANDARD MANDIBULAR

    MDR report key: 19960854 · Received August 12, 2024

    Report

    Report Number
    0001032347-2024-00251
    Event Type
    Injury
    Date Received
    August 12, 2024
    Date of Event
    August 9, 2023
    Report Date
    October 4, 2024
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. HETEROTOPIC OSSIFICATION (HO) IS THE ABNORMAL AND RAPID GROWTH OF BONE THAT FORMS WITHIN SOFT TISSUE AS THE RESULT OF HEREDITY, TRAUMA, SURGICAL HISTORY, OR DISEASES OF A JOINT. THE RAPID AND IRREGULAR GROWTH OF BONE OFTEN CAUSES A SHARP OR JUTTED STRUCTURE TO FORM, WHICH CAN RESULT IN PAIN AND IRRITATION TO THE SURROUNDING TISSUES, OR THE PATIENT CAN REMAIN ASYMPTOMATIC. RADIATION OR NONSTEROIDAL ANTI-INFLAMMATORY MEDICATIONS ARE OFTEN PROVIDED TO PREVENT HO FORMATION. THE ONLY TREATMENT, IF NECESSARY, IS SURGICAL EXCISION OR SHAVING/SMOOTHING OUT THE EXCESS BONE. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. IF ANY FURTHER INFORMATION IS FOUND THAT 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, D4, G3, G6, H2, H3, H4, H6, H10 AND H11.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). G2: CONSUMER: PATIENT. D10 ¿ MEDICAL PRODUCTS. ITEM# 24-6545, LOT# 531590; 45MM RT STND MANDIBULAR. ITEM# 24-6551, LOT# 190950; 50MM LFT STND MANDIBULAR. ITEM# 24-6560, LOT# 503370; TMJ MED RTFOSSA COMP. ITEM# 24-6561, LOT# 212890; TMJ MED LFT FOSSA COMP. 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

    IT WAS REPORTED THE PATIENT UNDERWENT A BILATERAL TMJ PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION DUE TO A BUILDUP OF BONE NEAR THE IMPLANT SITE. ALL IMPLANTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780499 45MM RT STANDARD MANDIBULAR JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 531590

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H