Equinoxe 320-35-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862534873), received between Apr 26, 2022 and Dec 4, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 1 YEAR(S), 6 MONTH(S) AND 11 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING IN WHICH TWO INFERIOR SCREWS WERE REPORTEDLY BROKEN LEADING TO GLENOID LOOSENING. THE PATIENT UNDERWENT A STANDARD REVERSE WITH PRESERVE STEM REVISION, WITH THE REPORTED REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW, GLENOID BASE PLATE, AND COMPRESSION SCREW/LOCKING CAP COMPONENTS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 20848827 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 10 MONTHS AFTER INITIAL RTSA, THE PATIENT EXPERIENCED A CORACOID SCAPULAR FRACTURE. THE EVENT IS REPORTED TO BE POSSIBLE RELATED TO THE PROCEDURE AND UNLIKELY RELATED TO THE DEVICE. NO ACTION WAS TAKEN (AWAITING ADDITIONAL TEST RESULTS). THE OUTCOME IS CONTINUING. THE IMPLANTS REMAIN IMPLANTED.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 19706037 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTRA-OPERATIVELY, THE INFERIOR GLENOID WAS FRACTURED DURING REAMING WITH THE K-WIRE IN PLACE. FIXATION WAS ACHIEVED WITH BASEPLATE SCREWS. THE SURGEON USED INTRA-OP STABILIZATION TO RESOLVE EVENT AND THE CASE REPORT INDICATED THAT IT IS DEFINITELY NOT RELATED TO THE DEVICE(S) BUT IS DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Bone Fracture(s); Limb Fracture

  MAUDE report 19630182 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2024, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2024. THE PATIENT FRACTURED HER GLENOID. NO FALL OR ACCIDENT OCCURRED. THE SURGEON REMOVED THE BASEPLATE, HAT, RECONSTRUCTED THE GLENOID, AND IMPLANTED A COMPETITOR¿S BASEPLATE AND EXACTECH TRAY AND LINER TO MATCH. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THE SURGEON KEPT THEM. NO FURTHER INFORMATION.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 18882197 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 4 YEARS, 2 MONTHS, AND 15 DAYS POST-OPERATIVELY OF AN INITIAL RTSA, THE PATIENT PRESENTED WITH ASEPTIC GLENOID LOOSENING. X-RAY SHOWS RTSA BASEPLATE FAILURE WITHOUT INCREASE IN PAIN OR TRAUMA; SUBJECT WAS LAST SEEN IN 2021. THE PATIENT UNDERWENT REVISION SURGERY AND THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS UNLIKELY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

  Patient problems: Aseptic loosening; Failure of Implant; Insufficient Information

  MAUDE report 18763374 ↗
• InjuryMar 6, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY THAT POST-OP THE 69 YO FEMALE PATIENT EXPERIENCED A SCAPULAR SPINE FRACTURE (TYPE 3) WITHOUT SPECIFIC KNOWN EVENT THAT WAS DIAGNOSED DURING ROUTINE FOLLOW-UP. THERE WAS NO REVISION. GPS WAS USED IN THE INITIAL IMPLANT PROCEDURE. PATIENT WAS ADVISED TO RESUME SLING FOR 6 WEEKS. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16492726 ↗
• InjuryNov 4, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 71 YO FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2022, WITH NO COMPLICATIONS, ¿POST OP X-RAYS LOOKED PERFECT¿, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE X-RAYS SHOWED THAT THE IMPLANT HAD EITHER ROTATED SUPERIORLY OR MIGRATED UP. THE DOCTOR REMOVED THE LINER, AND THEN REMOVED THE GLENOSPHERE AND ALL THREE SCREWS FROM THE BASEPLATE. HE THEN REMOVED THE SUPERIOR BASEPLATE AND FOUND THAT THE TOP 1/3 SUPERIOR/POSTERIOR HAD FRACTURED RESULTING IN THE BASEPLATE MIGRATING SUPERIOR. THE DOCTOR DECIDED TO SWITCH TO A TORNIER BASEPLATE AND USED A 39 GLENOSPHERE. ON THE HUMORAL SIDE, THE STEM AND +0 TRAY WERE WELL FIXED SO HE TRAILED WITH A 40 +2.5 LINER BUT WANTED A LITTLE MORE CONSTRAINT SO WENT WITH A 40+2.5 LINER. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Periprosthetic fracture

  MAUDE report 15729741 ↗
• InjuryApr 26, 2022Fracture; Fracture

  DURING THE INITIAL RIGHT TSA FOR THIS (B)(6) FEMALE PATIENT, THERE WAS A CRACK IN THE CORACOID NOTED DUE TO LOOSENING OF THE CORACOID GPS TRACKER. AT THIS POINT, THE LAST TWO SCREWS WERE PLACED WITHOUT COMPUTER NAVIGATION. THERE WAS NO ACTION TAKEN AND THE OUTCOME IS NOTED AS: CONTINUE TO UPDATE THIS ADVERSE EVENT UNTIL IT HAS BEEN RESOLVED. CURRENTLY, THERE IS NO UPDATED INFORMATION IN THE CLINICAL STUDY DATABASE. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 14207764 ↗