Introduction: Temporomandibular disorder (TMD) is a common, yet potentially debilitating syndrome that negatively impacts patient quality of life. In patients with severe variants of TMD, temporomandibular joint (TMJ) devices have been utilized to replace the joint altogether. However, the risk profile and consequent cost-benefit ratio of these devices is largely debated. This report aims to provide further insight on the safety of surgically implanted TMJ devices by analyzing adverse events from the Manufacturer and User Facility Device Experience (MAUDE) database.
Methods: Inclusion criteria consisted of all MAUDE reports from January 2013 to January 2023 containing the keyword "TMJ." Duplicate reports, pre-implantation events, reports extrapolated from published literature reviews, and those not related to TMJ implants were excluded from analysis. Adverse events were extracted, reviewed, and categorized according to complication type, management strategy, device manufacturer, causes of device malfunction, and reporting timeframe. Non-parametric χ2 and Levene's test were used to compare average values between groups with a two-tailed p value of 0.05 being considered statistically significant.
Results: A total of 385 adverse event reports were reviewed. The most common complications were infection (59, 25.9%), ankylosis (57, 25.0%), and pain (33, 14.5%). The most common device failures were implant malposition (28, 39.4%), implant dislodgement (22, 31.0%), and screw osseointegration failure (11, 15.5%). Upon assessment of revision surgeries, those undertaken to address infections had the highest rate of device explantation (77%). In a separate analysis of 28 adverse events submitted directly by patients, infection was most common self-reported complication (42.9%). Comparison of device manufacturers revealed that Biomet implants had significantly more reports of pain (χ2 = 10.21, p = 0.003), whereas Stryker implants had more infections (χ2 = 29.87, p < 0.001).
Conclusion: In summary, this in-depth analysis of adverse events provides a safety profile of TMJ implants. Understanding the complication types, management strategies, and outcomes according to device manufacturer may help set patient expectations and improve patient care.
S. Karger AG, Basel.