BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.H.JENSEN RIGHT PM-TMJ & MODEL

    MDR report key: 7210101 · Received January 22, 2018

    Report

    Report Number
    0001032347-2018-00036
    Event Type
    Injury
    Date Received
    January 22, 2018
    Date of Event
    October 11, 2017
    Report Date
    May 2, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P020016. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION BECAUSE IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(6).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT IS CONSIDERED CONFIRMED AS IT IS REPORTED THERE WAS AN EXPLORATORY PROCEDURE. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE PRODUCTS NOT BEING RETURNED AS THEY REMAIN IMPLANTED. THE REASON FOR THE EXPLORATORY SURGERY WAS CITED AS BEING SECONDARY TO PAIN, WHILE NO CAUSE WAS FOUND FROM THE EXPLORATORY SURGERY. THERE WAS NO ALLEGED MALFUNCTION OF THE IMPLANTS AND NO REMOVAL OF THE IMPLANTS. THE MANUFACTURING HISTORY WAS REVIEWED AND NO NON-CONFORMANCE WAS IDENTIFIED. ROOT CAUSE WAS UNABLE TO 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. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT SEVEN YEARS AFTER THE PATIENT WAS IMPLANTED WITH THE PATIENT MATCHED -TEMPOROMANDIBULAR JOINT (PM-TMJ) IMPLANT, THE PATIENT COMPLAINED OF INCREASED PAIN AND LIMITED MAXIMUM INTERCISAL OPENING/ DISTANCE (MIO). EXPLORATORY SURGERY WAS PERFORMED AND THE SURGEON DID NOT FIND ANY APPARENT REASON TO EXPLAIN THE PATIENT'S SYMPTOMS. THE IMPLANT WAS NOT REMOVED. THE EVENT WAS STATED TO NOT BE THE RESULT OF A DEVICE FAILURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54747 M.H.JENSEN RIGHT PM-TMJ & MODEL PATIENT MATCHED TMJ LZD BIOMET MICROFIXATION N/A 244270A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R