BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT

    MDR report key: 6076610 · Received November 3, 2016

    Report

    Report Number
    0001032347-2016-00639
    Event Type
    Injury
    Date Received
    November 3, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 4, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE JOINTS REMAIN IMPLANTED, THEREFORE NO PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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 FOUR FOR THE SAME EVENT, REFERENCE 0001032347-2016-00640, 0001032347-2016-00641, AND 0001032347-2016-00642.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED AS THE PRODUCTS REMAIN IMPLANTED. THERE WAS NO ALLEGED MALFUNCTION OF THE IMPLANTS. THE REVISION WAS PREFORMED TO REMOVE SCAR TISSUE MOST OFTEN IS COSMETIC IN NATURE. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS PATIENT CONDITION. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. SUPPLEMENTAL REPORT ONE OF FOUR FOR THE SAME EVENT, REFERENCE 0001032347-2016-00640-1, 0001032347-2016-00641-1, AND 0001032347-2016-00642-1.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A PROCEDURE TO REMOVE SCAR TISSUE ON BOTH SIDES. SHE STATED THE TMJ IMPLANTS WERE NOT REMOVED, ONLY THE SCAR TISSUE. IN ADDITION, SHE STATED EVERYTHING WAS A SUCCESS AND THERE WERE NO CHANGES TO HER CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726970 TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT 45MM RIGHT STANDARD MANDIBULAR LZD BIOMET MICROFIXATION N/A 405460A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other