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Revision Risk Following Primary Anatomic and Reverse TSA with an Exactech Equinoxe Compared with Other Devices: A
Heather A Prentice1, Richard N Chang1, Edward Yian2
1Medical Device Surveillance & Assessment, Southern California Permanente Medical Group, San Diego, California.
Background:
In 2024, Exactech issued a voluntary recall of Equinoxe devices after finding that some devices had been packaged in bags that were non-conforming because a secondary oxygen barrier layer of ethylene vinyl alcohol was missing. We sought to evaluate the revision risk following shoulder arthroplasty using an Exactech Equinoxe device compared with other eligible devices.
Methods:
We conducted a cohort study using data from a U.S. health-care system's shoulder arthroplasty registry. The study included 13,901 adult patients who had undergone primary elective anatomic total shoulder arthroplasty (ATSA), elective reverse total shoulder arthroplasty (RTSA), or RTSA for fracture (2005 to 2023). The mean age for the ATSA cohort (N = 8,707) was 68 years, 53.3% were male, and 84.7% were White. Corresponding values for the elective RTSA cohort (N = 4,374) were 74 years, 41.2% male, and 79.9% White, and those for the RTSA for fracture cohort (N = 820) were 73 years, 16.3% male, and 78.4% White. Multivariable Cox regression with covariate adjustment was used to evaluate all-cause revision risk for Equinoxe devices compared with other devices.
Results:
In adjusted analyses, a higher revision risk was observed for ATSAs with Equinoxe versus other devices (hazard ratio [HR] = 1.87, 95% confidence interval [CI] = 1.33 to 2.62). The higher revision risk was also observed in a subanalysis restricted to ATSAs with Equinoxe devices packaged in non-conforming bags (HR = 1.91, 95% CI = 1.34 to 2.72). No differences were observed in elective RTSAs (HR = 0.71, 95% CI = 0.33 to 1.49) or RTSAs for fracture (HR = 2.30, 95% CI = 0.84 to 6.28) with Equinoxe compared with other devices.
Conclusions:
We observed a higher revision risk with the use of Equinoxe devices in ATSA, but no difference for Equinoxe devices in elective RTSA compared with other devices. While all Equinoxe devices packaged in non-conforming bags were recalled worldwide in 2024, clinicians should be mindful of these findings when a patient had previously received an Equinoxe ATSA device.
Level Of Evidence:
Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
