BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 4915463 · Received July 15, 2015

    Report

    Report Number
    0001032347-2015-00307
    Event Type
    Injury
    Date Received
    July 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THESE TYPES OF EVENTS CAN OCCUR. THE JOINT REMAINS IMPLANTED, THEREFORE NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT ONE OF TWO FOR THE SAME EVENT, SEE ALSO 1032347-2015-00308.

    Description of Event or Problem · 1

    A UNILATERAL JOINT REPLACEMENT PATIENT REPORTED THROUGH THE TMJ CLINICAL STUDY PAIN, SWELLING, INTERFERENCE WITH EATING, FACIAL NERVE AND TRIGEMINAL NERVE DAMAGE. SHE ALSO INDICATED INFECTION, UPON FOLLOW UP SHE STATED THE (B)(6) INFECTION WAS NOT AT THE IMPLANT SITE AND DID NOT AFFECT THE IMPLANTS AND SHE HAS SINCE BEEN NEGATIVE FOR MRSA. SHE REPORTS TREATMENTS INCLUDING PHYSICAL THERAPY, STEROIDS AND PAIN MEDICATIONS WITH NO RESOLUTION. SHE ALLEGES THAT SHE HAS FREY'S SYNDROME ON THE LEFT SIDE DUE TO HER PAROTID GLAND BEING AFFECTED DURING SURGERY. SHE STATES HER OCCLUSION IS POOR, THEREFORE SHE HAS DIFFICULTLY EATING. THE PATIENT ALSO STATES SHE SUFFERS FROM MASSETER SPASMS ON THE LEFT SIDE WHEN SHE EATS. THE SURGEON'S OFFICE HAS NOT BEEN REACHED FOR CONFIRMATION OF THE REPORTED EVENTS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459123 TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM TMJ LEFT FOSSA LZD BIOMET MICROFIXATION N/A 122800A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| S