Equinoxe 320-35-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862534880), received between Sep 12, 2022 and Jul 13, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2026Migration

  IT WAS REPORTED THAT A PATIENT, WHO HAD RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT REPORTED HAVING PAIN SINCE THEIR SURGERY. THEY INDICATED THAT NO INJURY HAD OCCURRED. IT WAS OBSERVED THAT THE BASEPLATE AND GLENOSPHERE WERE DISLODGED FROM THE GLENOID. THE GLENOID COMPONENTS, HUMERAL TRAY, & LINER WERE REMOVED. THE CONSTRUCT WAS CONVERTED TO A HEMIARTHROPLASTY. 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. DEVICE MIGRATION WAS OBSERVED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. A PHOTO OF THE DEVICES WAS PROVIDED. PROSTHESIS WEAR WAS OBSERVED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

  Patient problems: Pain

  MAUDE report 25808024 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 0 YEAR(S) AND 3 MONTH(S) POST-OPERATIVE OF A LEFT IMPLANTED TSA, THE PATIENT PRESENTED WITH UNEXPLAINED PAIN. IT WAS REPORTED THE PATIENT EXPERIENCED PAIN LIFTING A GALLON OF MILK. THIS OUTCOME OF THE EVENT IS REPORTED TO BE RESOLVED WITH NO ACTIONS TAKEN. THE CLINICAL REPORT INDICATES THAT THE EVENT IS UNLIKELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Pain

  MAUDE report 19570423 ↗
• InjuryFeb 29, 2024Adverse 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 LEFT TSA ON (B)(6) 2021 AND PRESENTED WITH SCAPULAR SPINE FRACTURE (TYPE 3), APPROXIMATELY 0 MONTH(S) AND 2 YEAR(S) POST-OPERATIVELY ON (B)(6) 2023. DISPLACED SCAPULAR SPINE FRACTURE. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING, WITH THE ACTION TAKEN OF OTHER - CONSIDERING ORF. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 18811270 ↗
• InjuryJul 12, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2022. THE PATIENT PRESENTED WITH LOOSENING OF GLENOID SIDE COMPONENTS. NO INFECTION WAS PRESENT. THE PATIENT WAS REVISED ON (B)(6) 2023 AND THE SURGEON REMOVED THE GLENOID IMPLANTS, AND PACKED IT WITH BONE GRAFT. THE IMPLANT WAS CONVERTED TO A HEMI AND THE PATIENT WILL REVISIT IN 3 MONTHS TO DETERMINE WHEN A REVERSE CAN BE IMPLANTED. 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. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17313448 ↗
• InjurySep 14, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2021. THE PATIENT PRESENTED WITH A CORACOID FRACTURE AND THE FRACTURE WAS REPAIRED. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 15417265 ↗
• MalfunctionSep 12, 2022Break; Defective Device; Break; Defective Device

  AS REPORTED, THE SURGEON IMPACTED THE GLENOID BASEPLATE AND PROCEEDED TO PUT IN HIS COMPRESSION SCREWS AND LOCKING CAPS. AFTER HIS LOCKING CAPS WERE TIGHTENED HE WENT TO PLACE THE SMALL 36 GLENOSPHERE OVER THE SMALL POSTERIOR 8 DEGREE BASEPLATE. ONCE THE GLENOSPHERE WAS SEATED ON THE BASEPLATE THE SURGEON PROCEEDED TO INSERT THE GLENOSPHERE LOCKING SCREW. THE SURGEON STATES THAT THE SCREW WOULD JUST TURN AND NOT ENGAGE INTO THE CAGE. WHEN THE SURGEON EXPLANTED THE ORIGINAL POSTERIOR 8 DEGREE AUGMENTED BASEPLATE, HE NOTICED THAT THERE WERE NO SCREW THREADS IN THE BASEPLATE ITSELF. HE IS CONFIDENT THAT HE DID NOT STRIP OUT THE THREAD, BECAUSE THERE WAS NO EVIDENCE OF METAL DEBRIS. THE SURGEON ASKED TO OPEN UP A NEW BASEPLATE AND LOCKING SCREW. THE THREADS WERE VISIBLE AND THE SECOND BASEPLATE AND LOCKING SCREW IMPLANTED AS EXPECTED. THERE WAS A 15-30 MINUTE DELAY DUE TO FIGURING OUT AN ALTERNATIVE METHOD OF REMOVING THE BASEPLATE. THE SURGEON WANTED TO BE ABLE TO REMOVE THE IMPLANT BY PULLING STRAIGHT OUT, COMPARED TO ADDING ANY TORSIONAL OR LEVERING FORCES. HE ULTIMATELY USED A BONE FORCEPS TO PULL THE IMPLANT OUT. THE PATIENT CONTINUED WITH SURGERY WITH NO KNOWN ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407634 ↗