Adverse Events Associated with Surgically Implanted Temporomandibular Joint Devices

Area of Science:

• Orthopedic Surgery
• Biomaterials Science
• Medical Device Regulation

Background:

• Temporomandibular disorder (TMD) significantly impacts quality of life.
• Severe TMD cases may necessitate temporomandibular joint (TMJ) replacement devices.
• The safety and cost-benefit ratio of TMJ implants remain subjects of debate.

Purpose of the Study:

• To analyze adverse events associated with surgically implanted TMJ devices.
• To provide insights into the safety profile of TMJ implants.
• To identify common complications and device failures.

Main Methods:

• Analysis of 385 adverse event reports from the MAUDE database (2013-2023).
• Inclusion of reports with the keyword "TMJ," excluding duplicates and irrelevant cases.
• Categorization of adverse events by complication type, management, manufacturer, and cause.

Main Results:

• Infection (25.9%), ankylosis (25.0%), and pain (14.5%) were the most frequent complications.
• Common device failures included malposition (39.4%), dislodgement (31.0%), and screw osseointegration failure (15.5%).
• Revision surgeries for infection had a high explantation rate (77%); Biomet implants showed more pain reports, Stryker more infections.

Conclusions:

• This analysis establishes a safety profile for TMJ implants based on adverse event data.
• Identifying complication types and manufacturer-specific trends can enhance patient care.
• Improved understanding may help manage patient expectations regarding TMJ implant outcomes.