Equinoxe 314-13-13 (UDI 10885862657947)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862657947), received between Nov 18, 2025 and Aug 7, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2026Naturally Worn

  As reported, the patient underwent an initial right total shoulder arthroplasty. Subsequently, the patient was revised due to infection. An image provided noted subscap infiltration. The patient received a custom glenoid and competitor humeral components. There was no reported breakage of a device or surgical delay/prolongation.

  Patient problems: Metal Related Pathology; Muscle/Tendon Damage; Unspecified Infection

  MAUDE report 50171980 ↗
• InjuryJun 26, 2026Loss of Osseointegration; Detachment of Device or Device Component

  AS REPORTED, APPROXIMATELY 6 YEARS AND 11 MONTHS POST THE INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY, THE GLENOID COMPONENT LOOSENED AND DETACHED FROM THE PEGS. THE PATIENT WAS REVISED TO REVERSE COMPONENTS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Aseptic loosening

  MAUDE report 25636595 ↗
• InjuryFeb 11, 2026Naturally Worn

  IT WAS REPORTED THAT AN 89 YO MALE PATIENT, WHO HAD A RIGHT TSA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 YEARS 3 MONTHS POST THE INITIAL PROCEDURE. FAILED LASER CAGE GLENOID WAS REPORTED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE AVAILABLE FOR RETURN. NO IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Discomfort

  MAUDE report 24318648 ↗
• InjuryNov 18, 2025Loss of Osseointegration; Lack of Effect; Loss of Osseointegration; Lack of Effect

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMIC TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED GLENOID LOOSENING, GLENOID BONE LOSS AND LOSS OF RANGE OF MOTION. AS A RESULT, APPROXIMATELY, NINE YEARS AND TEN MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Osteolysis

  MAUDE report 23581415 ↗