BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 7940264 · Received October 5, 2018

    Report

    Report Number
    0001032347-2018-00678
    Event Type
    Injury
    Date Received
    October 5, 2018
    Report Date
    February 28, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT IDENTITY COULD NOT BE CONFIRMED DUE TO THE PARTS NOT BEING RETURNED. THE COMPLAINT DOES NOT IDENTIFY THE IMPLANTS THAT WERE USED. NO PRODUCT WAS RETURNED, THEREFORE NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIAN'S REPORTS WERE PROVIDED. THE COMPLAINT IS NON-VERIFIABLE. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT WARNS OF THE POTENTIAL FOR COMPLICATIONS. IT STATES IN THE SECTION TITLED ADVERSE EVENTS: DISLOCATION. IT ALSO STATES IN THE SECTION TITLED PATIENT COUNSELING INFORMATION: DISCUSSION OF THE FOLLOWING POINTS IS RECOMMENDED PRIOR TO SURGERY. 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. ADDITIONAL TREATMENT MAY BE REQUIRED INCLUDING BUT NOT LIMITED TO EXTENDED PHYSICAL THERAPY, BITE SPLINT, DENTAL BRACES, AND/OR ORTHOGNATHIC AND RECONSTRUCTIVE SURGERY. THE DEVICE HISTORY RECORD (DHR) FOR THIS PRODUCT COULD NOT BE REVIEWED DUE TO THE PART AND LOT NUMBERS BEING UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN COUNTRY - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, IT REMAINS IMPLANTED AT THIS TIME. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAS DISPLACEMENT OF THE GLENOID FOSSA. THE SURGEON HAS REQUESTED A RECOMMENDATION FOR HOW TO PROCEED WITH THIS CASE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780730 WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention