Outcomes and Survivorship of Biomet Microfixation Total Joint Replacement System: Results From an FDA Postmarket Study.

ABSTRACT

PURPOSE: In February 2011, the Food and Drug Administration issued a postmarket surveillance order to all manufacturers of temporomandibular joint (TMJ) implants in the United States. The objective of the present study was to measure implant subsequent surgical intervention (SSI) among patients who had undergone TMJ reconstruction with the Biomet TMJ replacement system (Zimmer Biomet, Warsaw, IN). MATERIALS AND METHODS: A prospective observational study was conducted by sending a questionnaire to patients who had received a Biomet TMJ replacement system from 1995 to 2010 in the United States. The questionnaire was sent annually from 2012 to 2015. The primary endpoint was the SSIs. SSIs included both device removal and reoperations. Kaplan-Meier survival analysis was used to determine the survivorship, and Cox proportional hazard regression analysis was performed to evaluate the preoperative diagnosis and SSI. RESULTS: The mean age at implantation was 46.6 ± 12.5 years, with a gender distribution of 86.1% female. Data from 499 joints in 319 subjects were collected as a part of the survey. The mean follow-up time was 8.6 ± 3.9 years (range, 2-20 years). The first SSI frequency was 11.2% (4.2% removal rate and 7.0% reoperation rate). The survivorship rate (Kaplan-Meier) was 96% at 3 years, 94% at 5 years, and 86% at 10 years. The mean interval to failure using a survival function to determine the time to SSI (Greenwood's formula) was 13.5 ± 0.193 years. The most common causes of SSI included adhesion removal (2.6%; 13 of 498), heterotopic bone/ankylosis (2.0%; 10 of 498), and infection (1.6%; 8 of 498). CONCLUSIONS: The results from the present study are consistent with the reported survivorship rates for other orthopedic devices (5-year survival for total hip or knee arthroplasty, 95.9 and 97.2%, respectively). The etiology of SSIs in the Biomet TMJ replacement system was primarily secondary to biologic failure (ie, adhesions, heterotopic bone, and infection).