The Journal of bone and joint surgery. American volume
September 15, 2026 · via Europe PMC
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, +7 more, Paxton EW.
AI summary — for doctors, generated from the abstract only
In a large US cohort study prompted by a 2024 device recall, patients who received an Exactech Equinoxe anatomic total shoulder replacement had nearly twice the risk of needing revision surgery compared with other shoulder replacement devices, though this increased risk was not seen with the same brand's reverse shoulder replacements.
What was studied
A cohort study using a U.S. health system's shoulder arthroplasty registry of 13,901 adult patients who underwent primary anatomic total shoulder arthroplasty (ATSA, n=8,707), elective reverse total shoulder arthroplasty (RTSA, n=4,374), or RTSA for fracture (n=820) between 2005-2023, comparing all-cause revision risk for Exactech Equinoxe devices versus other devices using multivariable Cox regression, prompted by a 2024 voluntary recall of some Equinoxe devices due to defective packaging.
Key findings
- In adjusted analyses, anatomic total shoulder arthroplasty (ATSA) with an Equinoxe device had a significantly higher revision risk than other devices (hazard ratio 1.87, 95% CI 1.33-2.62).
- This higher revision risk persisted in a subanalysis restricted specifically to Equinoxe devices packaged in the recalled non-conforming bags (HR 1.91, 95% CI 1.34-2.72).
- No significant difference in revision risk was observed for elective reverse total shoulder arthroplasty (HR 0.71, 95% CI 0.33-1.49) or reverse arthroplasty for fracture (HR 2.30, 95% CI 0.84-6.28) using Equinoxe versus other devices.
Clinical relevance
The findings suggest that patients who previously received an Equinoxe anatomic total shoulder replacement (even those not specifically recalled) may warrant closer monitoring given the elevated revision risk observed, while this concern does not appear to extend to Equinoxe reverse shoulder replacements, which is directly relevant to surgeons managing patients with these implants.
Who should care
Limitations
This is an observational registry cohort study, not a randomized comparison, so unmeasured differences between patients or surgical practices associated with device choice could contribute to the observed difference; the reverse arthroplasty for fracture subgroup had a wide confidence interval (0.84-6.28) reflecting limited statistical power in that smaller group.
Exactech Equinoxe anatomic total shoulder replacements were linked to nearly double the revision risk of other devices following a 2024 packaging-related recall, while reverse shoulder replacements from the same manufacturer showed no such increased risk.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
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.
DOI
10.2106/jbjs.25.01594
PMID
42743297
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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