The TMJ Association, Ltd. (TMJA) presents this solely as an informational guide based on the number of questions we receive for specific information on available devices. The TMJ Association does not endorse any specific prosthetic device for use in the TM joint nor do we endorse any of the devices of the companies listed. Feel free to contact the TMJA with any TMJ implant questions or concerns you may have at firstname.lastname@example.org.
Jaw Joint Devices
There are different types of TMJ implants. Some replace only a part of the jaw joint, such as the glenoid fossa (skull socket) or the condyle; others replace the entire joint (skull socket and condyle) (total joint replacement).
The purpose of these implants is to restore jaw function. However, all movements of a normal joint may not be possible with an artificial joint. Even though many patients experience some relief from their symptoms, the amount of pain reduction will vary from patient to patient over time, and some patients may even experience more pain. A variety of artificial materials have been used to partially or totally replace the TMJ, including plastics, click here to learn more about the history of TMJ implants.
Replacement of the temporomandibular joint with an implant should be considered a last resort, after trying all other forms of treatment. When used in patients who have had multiple prior jaw joint surgeries it may improve function, but studies have shown that it may not significantly reduce pain. Patient data indicates that those who have undergone two or fewer previous surgeries experience less pain postoperatively than those who have undergone larger numbers of prior operations.
Before undergoing surgery on the jaw joint, it is extremely important to get other independent opinions.
Inflammatory or immunological responses in some of these patients may preclude further reconstruction with bone from the patient. This population of patients often has severe pain and extremely limited function, including patients with severe trauma to the temporomandibular joint, neoplasms (tumors), congenital deformities, ankylosis, or arthritis involving the TMJ, rendering the joint dysfunctional.
Patients should discuss with an oral surgeon the risks and benefits before having any device implanted. Some questions you may want to ask include:
- How long has the device been on the market and who manufacturers it?
- Is this a custom or stock device? Is this the right implant for me?
- Does the labeling on the device indicate that this is a temporary or permanent implant? If temporary, how long is the implant intended to remain functional?
- What are the advantages and disadvantages of having the device implanted?
- What are the possible complications or risks during the procedure?
- What are the possible complications or side-effects after the procedure?
- What effect does my medical history have on the outcome of this surgery?
- Are there alternatives to this surgery? What are they?
- Should I have a metal sensitivity test done prior to the procedure
- What problems have been reported with this device?
- Who should I tell if I have a problem?
- What records should I keep?
- Will there be changes in my appearance?
- Does my insurance cover this surgery and implant?
- How often will I see you for follow-ups after the procedure?
How to Report a Device Problem
Should you be experiencing any type of TMJ device problem, it is important that you report these issues here.
The FDA’s device tracking regulation requires manufacturers, distributors, and hospitals to establish systems to track medical devices that are subject to the regulation, including TMJ implants, which have been tracked devices since August 1993. Manufacturers should be able to contact patients who receive TMJ implants through these tracking systems.
You should notify the doctor who performed the TMJ implant surgery or the manufacturer of your TMJ implant of any address changes so that manufacturers can easily notify you about any problems with a TMJ implant.
TMJ Implant Device Manufacturers
The following TMJ implant device manufacturers are FDA approved to market their devices:
- TMJ Concepts (formerly Techmedica) https://tmjconcepts.com/tmj/files/TMJ-Patient-Information-Brochure_52-0100-G.pdf
- Zimmer Biomet (formerly Walter Lorenz Surgical, Inc.) https://www.zimmerbiomet.com/content/dam/zimmer-biomet/medical-professionals/cmf-thoracic/total-joint-replacement-system/total-joint-replacement-system-brochure.pdf
The surgical procedure to place a total TMJ prosthesis involves admission to a hospital and surgery under general anesthesia. Several different incisions may be made to access the area of the TMJ. The common incisions are just in front of the ear and under the mandible.
In total joint replacement surgery, the natural condyle is removed and the artificial condyle is attached to the lower jaw with screws. The fossa portion of the implant is also attached with screws to the skull base just in front of the internal bony portion of the ear.
Recovery time varies depending on the individual patient factors. Following surgery, the surgeon will recommend a specific diet and a series of exercise to help regain function. Patients may need further pain management and physical therapy to achieve improved results.
We invite you to read our list of tips to prepare for a TMJ surgery.
Reporting of Device Problems
The FDA is charged with helping to ensure the safety and effectiveness of medical products, including medical devices used to treat temporomandibular disorders such as TMJ implants. The FDA assesses TMJ implants before they are marketed and monitors their subsequent performance, taking action when problems are discovered. The FDA also monitors reports of adverse events and other issues with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. You can view device reports at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
FDA medical device reports (MDRs) on TMJ Implants show:
- Approximately 5,500 TMJ total joint replacement procedures were performed in U.S. from 2005 to 2014 (Journal of Oral and Maxillofacial Surgery, Volume 74, Issue 8, 1531 – 1538).
- The FDA received 680 MDRs related to TMJ implants from 2014-2018, prompting increased efforts on patient engagement, looking at patient reported outcomes, and initiating a review of post-market studies.
The most frequent patient problems reported in the MDRs included pain, swelling, infection, additional surgical procedure (including revision or additional procedures), headache, limited mobility of the implanted joint, ossification, hypersensitivity, disability, and additional therapy/non-surgical treatment.
MedEffect Canada has a similar reporting system in Canada in which Canadians can report problems with their medical devices. https://hpr-rps.hres.ca/side-effects-reporting-form.php?form=voluntary&lang=en
We are grateful to Dr. Daniel Laskin, Adjunct Clinical Professor and Chairman Emeritus at Virginia Commonwealth University School of Dentistry, Oral and Maxillofacial Surgery, for his many years as our clinical advisor and for writing the content in this section.