Equinoxe 310-61-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862537126), received between Nov 22, 2023 and Mar 31, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Migration

  IT WAS REPORTED THAT A 58 YO MALE PATIENT, WHO HAD A LEFT PRIMARY TSA, UNDERWENT A REVISION TO REMOVE A STEMLESS PRIMARY TSA AND LASER CAGE GLENOID. THE SURGEON POINTED OUT IT WAS APPARENT THAT THE OVERHANG OF THE HEAD IMPLANT CONTRIBUTED TO THE FAILURE OF THE SUBSCAPULARIS. ONCE THE HEAD AND HUMERAL COMPONENT WERE REMOVED, THEY MOVED TO THE GLENOID WHERE THE LASER CAGE GLENOID WAS REMOVED WITH AN OSTEOTOME. THE CENTRAL PEG AND INFERIOR PEGS WERE EXPLANTED BUT THEY WERE UNABLE TO REMOVE THE SUPERIOR PEG WITHOUT CAUSING TOO MUCH DAMAGE, SO IT WAS LEFT IN. AN ABX SHOULDER SPACER WAS REIMPLANTED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE HEAD IMPLANT APPEARS TO BE DISLOCATED IN THE IMAGING. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THE HOSPITAL WILL NOT RELEASE THEM. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Arthropathy

  MAUDE report 24738237 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL TSA ON (B)(6) 2020. THE PATIENT PRESENTED ON (B)(6) 2020 WITH COMPLAINS OF PERSISTING STIFFNESS AND DISCOMFORT AFTER ORIGINAL ARTHROPLASTY - REVISED DONE ON (B)(6) 2020. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. OUTCOME IS RESOLVED ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 18196986 ↗