BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 6540022 · Received May 3, 2017

    Report

    Report Number
    0001032347-2017-00339
    Event Type
    Injury
    Date Received
    May 3, 2017
    Report Date
    May 20, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. THESE TMJ IMPLANTS WERE STERILIZED PRIOR TO DISTRIBUTION. FOR THE AFOREMENTIONED REASONS, THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT STATES IN THE SECTION TITLED ADVERSE EVENTS: ADVERSE EVENTS THAT MAY OCCUR FOLLOWING PLACEMENT OF THE TOTAL TMJ REPLACEMENT SYSTEM ARE LISTED BELOW. REMOVAL OF COMPONENTS(S) INCLUDING, BUT NOT LIMITED TO THE FOLLOWING: DEGENERATIVE CHANGES WITHIN THE JOINT SURFACES FROM DISEASE OR PREVIOUS IMPLANTS. INFECTION (SYSTEMIC OR SUPERFICIAL). FOREIGN BODY OR ALLERGIC REACTION TO IMPLANT COMPONENTS. FACIAL SWELLING AND/OR PAIN. NEUROMA FORMATION. THE IFU ALSO STATES IN THE SECTION TITLED PATIENT COUNSELING INFORMATION: DISCUSSION OF THE FOLLOWING POINTS IS RECOMMENDED PRIOR TO SURGERY. THE IMPORTANCE OF PROMPT MEDICAL ATTENTION IF THEY EXPERIENCE UNUSUAL SWELLING IN THE AREA OF THE IMPLANT. THE RISKS ASSOCIATED WITH A TOTAL TMJ SYSTEM (SEE WARNINGS AND ADVERSE EVENTS). POST-OPERATIVE PAIN RELIEF AND RETURN OF FUNCTION VARIES FROM PATIENT TO PATIENT. THIS IS REPORT ONE OF TWO FOR THE SAME EVENT. REPORT TWO OF TWO IS REPORTED ON MFR #0001032347-2017-00340-2

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND THEREFORE WILL NOT BE RETURNED FOR AN EVALUATION. WITHOUT A PRODUCT RETURN, 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. THIS IS REPORT ONE OF TWO FOR THE SAME EVENT. REPORT TWO OF TWO IS REPORTED ON MFR #0001032347-2017-00340.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2017-00340-3.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HAVING TROUBLE WITH HER IMPLANTS. THE PATIENT HAD FLUID BUILD UP BEHIND THE IMPLANTS. IT WAS DESCRIBED AS A "BUBBLE ON HER FACE." THE PATIENT STATES HER HEADACHES ARE WORSE. THE PATIENT HAD THE FLUID DRAINED IN THE DOCTOR'S OFFICE. THE DOCTOR PRESCRIBED A MEDICATION; THE PATIENT IS NOT SURE OF THE PRESCRIPTION'S NAME. THE PATIENT STATES SHE "DID NOT GET BETTER."

    Description of Event or Problem · 1

    THE LEGAL DEPARTMENT RECEIVED NOTIFICATION OF A NEW CLAIM. THROUGH A REVIEW OF THE LEGAL DOCUMENTS, IT WAS DETERMINED THAT THERE WAS NEW INFORMATION NOT ORIGINALLY REPORTED. DATE OF SYMPTOMS ONSET: (B)(6)2017 INCLUDING PAIN, SWELLING IN FACE AND JAW, WOUND DRAINAGE, AND INTERMITTENT FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324204 WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM TEMPOROMANDIBULAR JOINT (TMJ), IMPLANT, TMJ MEDIUM RIGHT FOSSA COMPONENT LZD BIOMET MICROFIXATION N/A 657570B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention