Equinoxe 314-13-35 (UDI 10885862658043)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862658043), received between Oct 28, 2025 and Oct 28, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT A 66 YO MALE PATIENT, WHO HAD A RIGHT TSA UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO SHOULDER PAIN AND SUSPICION OF A SHOULDER INFECTION. DURING THE PROCEDURE, THE HUMERAL HEAD AND STEMLESS HUMERAL COMPONENT WERE REMOVED WITHOUT ISSUE. THE GLENOID WAS EASY TO REMOVE AS IT WAS CLEAR THERE WAS A MECHANICAL FAILURE OF THE PLASTIC BEHIND THE GLENOID IN THE CENTRAL CAGE CAUSING THE LOOSENING*. UPON REMOVAL OF THE CENTRAL CAGE, THE EXTRACTION DEVICE REMOVED A LITTLE OVER HALF THE LENGTH OF THE CENTER CAGE. THE SURGEON COULDN'T REMOVE THE LITTLE AMOUNT OF HARDWARE LEFT WITHOUT CAUSING ADDITIONAL TRAUMA TO THE GLENOID, SO IT WAS LEFT IN. ALL OF THE PERIPHERAL PEGS WERE REMOVED. SHE WAS ABLE TO PERFORM THE REVERSE TSA AND WORK AROUND THE HARDWARE THAT WAS STILL IN THE GLENOID. ONCE ALL PARTS WERE REMOVED, IT WAS DETERMINED THAT AN ANTIBIOTIC SPACER WAS NOT NECESSARY, AND THE SURGEON PERFORMED A REVERSE TOTAL SHOULDER USING A COMPETITOR¿S DEVICES. THERE WAS DEVICE BREAKAGE DURING THE EVENT ¿ THE POLY PEG WITHIN THE CENTRAL CAGE WAS BROKEN AND LEFT IN TO MITIGATE FURTHER TRAUMA TO THE GLENOID.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23407913 ↗