Equinoxe anatomic shoulder replacements had nearly double the revision risk of other devices

Design

Retrospective cohort, US health-system shoulder arthroplasty registry

Population

13,901 primary anatomic and reverse shoulder arthroplasties, 2005 to 2023

Primary outcome

All-cause revision

Effect

Anatomic TSA HR 1.87 (1.33 to 2.62); elective reverse HR 0.71 (0.33 to 1.49)

In 2024 Exactech recalled Equinoxe shoulder devices packaged in bags missing an oxygen barrier layer, raising concern about polyethylene oxidation. This cohort from a large US health-system registry compared revision risk for Equinoxe against other devices in 13,901 primary shoulder arthroplasties from 2005 to 2023.

For anatomic total shoulder arthroplasty, Equinoxe carried a higher adjusted revision risk (HR 1.87, 95% CI 1.33 to 2.62), and the risk was the same when restricted to devices in the non-conforming packaging (HR 1.91). For elective reverse arthroplasty there was no difference (HR 0.71, 0.33 to 1.49), and for reverse arthroplasty after fracture the estimate was imprecise (HR 2.30, 0.84 to 6.28).

The practical consequence is for follow-up: patients with an Equinoxe anatomic shoulder need a lower threshold for review and imaging when symptoms change.

• Check implant records for patients with a shoulder replacement from affected years
• Review patients with an Equinoxe anatomic shoulder promptly if pain, stiffness or clunking develops
• Look for polyethylene wear and osteolysis on radiographs at follow-up
• Reverse Equinoxe arthroplasties showed no excess revision in this cohort

Why it matters

It quantifies the clinical impact of a packaging recall that many surgeons have been asked about.

Don't overread it

This is observational registry data from one US system; revision is a surgeon decision and may be influenced by recall awareness.

The statistics, in plain English

A hazard ratio of 1.87 means nearly twice the rate of revision at any point. The reverse-for-fracture interval (0.84 to 6.28) is too wide to conclude anything.

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