JBJS - 2026-09-15 - Journal Article
Revision Risk Following Primary Anatomic and Reverse TSA with an Exactech Equinoxe Compared with Other Devices: A U.S.-Based Cohort Study.
Prentice HA, Chang RN, Yian E, Navarro RA, Singh A, Chan DP, Ding D, Elwell JA, Degrasse J, Roche C, Paxton EW
Topics
Key Takeaway
Exactech Equinoxe ATSA carries an 87% higher all-cause revision risk versus other devices (HR 1.87, 95% CI 1.33–2.62), while elective RTSA with Equinoxe shows no significant difference.
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Summary
This registry-based cohort study evaluated all-cause revision risk for Exactech Equinoxe shoulder arthroplasty devices versus all other devices using multivariable Cox regression across three surgical cohorts. Equinoxe ATSA demonstrated HR 1.87 (95% CI 1.33–2.62) for revision, with the non-conforming bag subgroup yielding nearly identical risk (HR 1.91, 95% CI 1.34–2.72). Elective RTSA showed no significant difference (HR 0.71, 95% CI 0.33–1.49), and RTSA for fracture trended toward higher risk but was underpowered (HR 2.30, 95% CI 0.84–6.28).
Key Limitation
Failure mode was not captured; without knowing whether revisions were driven by accelerated polyethylene wear, aseptic loosening, or other mechanisms, the causal link between the packaging defect and elevated ATSA revision risk remains inferential.
Original Abstract
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.