Anatomic shoulder replacements with Exactech Equinoxe devices were revised more often

Design

Registry-based retrospective cohort with multivariable Cox regression

Population

13,901 adults with primary anatomic or reverse total shoulder arthroplasty, 2005–2023

Primary outcome

All-cause revision

Effect

Anatomic TSA Equinoxe vs other: HR 1.87 (1.33–2.62); elective reverse TSA: HR 0.71 (0.33–1.49)

In 2024 Exactech recalled Equinoxe shoulder devices worldwide after some were found packaged in bags missing a secondary oxygen barrier layer. This cohort from a US health-system registry compared revision risk in 13,901 primary shoulder arthroplasties done between 2005 and 2023.

For anatomic total shoulder arthroplasty, Equinoxe devices had a higher adjusted risk of all-cause revision than other devices (HR 1.87, 95% CI 1.33–2.62). The excess was the same when limited to devices packaged in the non-conforming bags (HR 1.91, 1.34–2.72). There was no significant difference for elective reverse arthroplasty (HR 0.71, 0.33–1.49) or reverse arthroplasty for fracture (HR 2.30, 0.84–6.28).

The recall has removed affected stock, so the practical question is the patients already implanted. The authors advise being mindful of the device in anyone presenting with a painful or failing anatomic Equinoxe replacement. Where patients in India received these devices, the same applies, though local recall reach is not documented here.

• Check operative records for the implant used in any patient with a painful anatomic shoulder replacement
• Examine and image Equinoxe anatomic replacements for polyethylene wear and glenoid loosening at follow-up
• Contact patients with affected devices who have been lost to follow-up where records allow
• Do not revise asymptomatic, well-functioning replacements on the basis of this study alone

Why it matters

A recall ends future implantation, but thousands of patients already carry the device.

Don't overread it

The recall was for packaging; this registry shows higher revision but cannot prove the packaging defect caused it.

The statistics, in plain English

A hazard ratio of 1.87 means the revision rate was nearly twice that of other devices after adjustment. The reverse arthroplasty for fracture result (HR 2.30, 0.84–6.28) is too imprecise to say anything, because the interval spans a reduction and a large increase. This is an observational registry, so differences in patients or surgeons choosing the device could contribute.

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