Equinoxe 320-35-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862534897), received between Oct 10, 2022 and Jan 10, 2023 — classified as 2 injuries.

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

• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY FIVE MONTHS POST INITIAL TSA, THE 71 Y/O FEMALE PATIENT EXPERIENCED SCAPULAR FRACTURE. PATIENT HAD CORACOID FIXATION. THE EVENT IS STILL ONGOING.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 16130962 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN OVER 75 YO FEMALE PATIENT, WHO HAD AN INITIAL SHOULDER PROCEDURE ON (B)(6) 2022, SUFFERED AN ACROMIAL STRESS FRACTURE. THE SURGEON EXCHANGED THE GLENOSPHERE, GLENOSPHERE LOCKING SCREW, HUMERAL TRAY, TORQUE SCREW AND HUMERAL LINER TO DETENTION THE PATIENT. THE PATIENT HAD 25 DEGREES OF GLENOID RETROVERSION. THE SURGEON USED AN AUGMENTED BASE PLATE AND EXPANDED GLENOSPHERE TO CORRECT VERSION AND MAINTAIN JOINT TENSION. IN HINDSIGHT HE REGRETS LATERALIZING HER WITH THE EXPANDED OPTION AND THINKS HE MAY HAVE OVER TENSIONED HER LEADING TO THE ACROMIAL FRACTURE .THERE WAS NO DIRECT TRAUMA TO THE SHOULDER. THE PATIENT HAD A LOW BMI AND WAS RELATIVELY HEALTHY CONSIDERING HER AGE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 15571392 ↗