Recalled Exactech Equinoxe anatomic shoulders: higher revision risk in a US registry

Design

Retrospective cohort from a US health-system shoulder arthroplasty registry, 2005–2023

Population

13,901 adults with primary anatomic or reverse total shoulder arthroplasty

Primary outcome

All-cause revision

Effect

Anatomic TSA: HR 1.87 (95% CI 1.33 to 2.62); elective reverse TSA: HR 0.71 (0.33 to 1.49)

In 2024 Exactech recalled Equinoxe shoulder components packaged in bags missing a secondary oxygen barrier layer. A US health-system registry has now compared revision risk in 13,901 shoulder arthroplasties performed between 2005 and 2023.

For anatomic total shoulder arthroplasty, Equinoxe devices carried about 1.9 times the adjusted risk of all-cause revision compared with other devices, and the excess was similar when the analysis was restricted to components packaged in the non-conforming bags. No difference was found for elective reverse shoulder arthroplasty, and the estimate for reverse arthroplasty after fracture was too imprecise to interpret.

The practical consequence is for surveillance rather than new implant choices, since the affected devices were withdrawn worldwide. Patients known to have an Equinoxe anatomic shoulder should have a low threshold for clinical and radiographic review if pain or loss of function develops. Whether this device reached Indian patients in meaningful numbers is not known from this study.

• Identify patients in your practice who received an Exactech Equinoxe anatomic total shoulder, using implant records.
• Review these patients promptly if they report new pain, stiffness or loss of function, with radiographs for loosening or wear.
• Explain to concerned patients that the higher risk was seen for anatomic, not elective reverse, replacements.
• Record implant details in every arthroplasty note so future recalls can be traced to individual patients.

Why it matters

A packaging fault in a recalled device has now been linked to a measurable clinical excess in revisions.

Don't overread it

This registry shows association; it cannot confirm that the packaging defect caused the revisions, and there was no excess for elective reverse shoulders.

The statistics, in plain English

A hazard ratio of 1.87 (95% CI 1.33 to 2.62) means revision happened at nearly twice the rate over follow-up. For reverse arthroplasty after fracture, the interval of 0.84 to 6.28 crosses 1.0, so no conclusion can be drawn.

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