Equinoxe 320-15-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862186676), received between Dec 18, 2020 and Sep 8, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Loosening of Implant Not Related to Bone-Ingrowth

  It was reported that the patient underwent a right shoulder replacement. Subsequently, the patient had a revision procedure due to glenoid component loosening associated with humeral impingement. The original components were explanted, and a competitor's device was implanted. The patient was last known to be in stable condition following the event. No further information is available.

  Patient problems: Joint Impingement

  MAUDE report 50669696 ↗
• InjuryMay 27, 2026Separation Failure; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT PREVIOUSLY UNDERWENT A LEFT SHOULDER REPLACEMENT AND SUBSEQUENTLY REQUIRED A REVISION SURGERY TO ADDRESS PAIN. BASED ON PROVIDED RADIOGRAPH, THE GLENOID COMPONENTS ARE SEEN TO BE NO LONGER BE FIXED WITHIN THE BONE AND APPEAR TO HAVE ROTATED. THE SURGEON¿S PLAN FOR THE REVISION PROCEDURE WAS TO REMOVE THE GLENOSPHERE, RECUT THE HUMERUS, AND IMPLANT NEW HUMERAL COMPONENTS. DURING THE PROCEDURE, THE SURGEON REMOVED THE FIXED-ANGLE TORQUE SCREW AND ATTEMPTED TO REMOVE THE HUMERAL ADAPTER TRAY; HOWEVER, THE STEM DISENGAGED AND WAS REMOVED WITH THE TRAY STILL ATTACHED. ATTENTION WAS THEN TURNED TO THE GLENOSPHERE. AFTER REMOVAL OF THE LOCKING SCREW, THE SURGEON ATTEMPTED TO DISENGAGE THE GLENOSPHERE FROM THE BASEPLATE USING MANUAL MANIPULATION. ADDITIONAL ATTEMPTS WERE MADE, HOWEVER, THE GLENOSPHERE AND BASEPLATE WERE ULTIMATELY REMOVED TOGETHER AS A SINGLE CONSTRUCT. THE SURGEON REMOVED ALL THE IMPLANTS AND MADE A HOMEMADE SPACER AS A FIRST STAGE REVISION PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Pain

  MAUDE report 25300091 ↗
• InjuryDec 4, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND DECREASED MOTION IN THE SHOULDER. AS A RESULT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION APPROXIMATELY 1 YEAR AFTER INITIAL IMPLANTATION. DURING THE REVISION SURGERY IT WAS NOTED THAT ONE OF THE PATIENT'S GLENOID SCREWS HAD FRACTURED WHICH LED TO LOOSENING OF THE GLENOID BASEPLATE. THE DISTAL PORTION OF THE SCREW WAS RETAINED IN THE PATIENT'S GLENOID. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 23716153 ↗
• InjuryMay 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED LOOSENING SECONDARY TO AN INFECTION IN THE LEFT SHOULDER. AS A RESULT, APPROXIMATELY 2 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: Septic loosening; Unspecified Infection

  MAUDE report 21972241 ↗
• InjuryMar 20, 2025Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  AS REPORTED, APPROXIMATELY 2 MONTHS AND 7 DAYS POST THE INITIAL RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY, X-RAY SHOWED MIGRATION OF THE AUGMENT AND GLENOSPHERE. UPON OPENING THE PATIENT, SUPERIOR FRACTURE OF THE GLENOID WAS DISCOVERED. ALL IMPLANTS WERE REMOVED; THERE WAS NO DAMAGE NOTED TO ANY IMPLANTS. A PRESS FIT STEM RETAINED AND CTA HEMI WERE 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.

  Patient problems: Bone Fracture(s)

  MAUDE report 21652559 ↗
• InjuryMar 13, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS 71 Y/O MALE PATIENT'S LEFT SHOULDER WAS REVISED APPROXIMATELY 1 YEAR 11 MONTHS POST OP. SURGEON BELIEVES THAT THERE WAS SCAPULAR NOTCHING WHICH CAUSED POLY WEAR/INSTABILITY. THE GLENOSPHERE WAS ALSO QUITE LOOSE WHICH SHE BELIEVES ALSO COULD HAVE BEEN A CAUSE. NEITHER PHYSICIAN NOR SALES REP HAD A VERY GOOD EXPLANATION FOR HOW THE SCREW BECAME LOOSE. THERE WAS NO BREAKAGE OF THE DEVICE. THERE WAS A A 30-40 MINUTES SURGICAL DELAY DUE TO ALL COMPONENTS OTHER THAN BASEPLATE/SCREWS AND STEM HAD TO BE REMOVED. NEW COMPONENTS TRIALED AND NEW IMPLANTS INSERTED; HOWEVER, THERE WAS NO ADVERSE EVENT AS A RESULT OF THE SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PHOTO ATTACHED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - HOSPITAL POLICY.

  Patient problems: Joint Impingement; Joint Laxity

  MAUDE report 21596866 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023, APPROXIMATELY 5 MONTHS POST THE INITIAL PROCEDURE. RAISED WHITE BLOOD CELL MARKERS CAUSED SUSPECTED INFECTION & SUBSEQUENT REMOVAL OF IMPLANTS. A CEMENT SPACER WAS IMPLANTED. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES REPORTED. NO X-RAYS WERE ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO DEVICE RETURNS ARE AVAILABLE AS THEY WERE DISPOSED OF. EXPLANT IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 18522437 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THRU EQUINOXE SHOULDER STUDY, APPROXIMATELY 2 YEARS POST OP THE INITIAL TSA, THIS 57 Y/O MALE PATIENT WAS PRESENTING WITH A SMALL SUSPICION FOR POSSIBLE INFECTION, SUBJECT HAD LABS DONE AND MET WITH ID IN GREENVILLE WHO PRESCRIBED ANTIBIOTICS INDEFINITELY. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. NO ADDITIONAL INFORMATION.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 15347003 ↗
• InjuryJun 8, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL TSA, THIS (B)(6) YEAR OLD MALE PATIENT WAS REVISED DUE TO SEPTIC LOOSENING. AT THE (B)(6) 2022 VISIT, THERE WAS SMALL SUSPICION FOR POSSIBLE INFECTION, SUBJECT HAD LABS DONE AND MET WITH ID IN GREENVILLE WHO PRESCRIBED ANTIBIOTICS INDEFINITELY. AT THE (B)(6) 2021 VISIT, XRAYS SUGGESTED LOOSENING OF THE GLENOID COMPONENT. AT (B)(6) 2021 VISIT, LOOSENING HAD PROGESSED. SCHEDULED FOR REVISION (B)(6) 2022. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 14631783 ↗
• InjuryDec 18, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 8 MONTHS POSTOP THE INITIAL RIGHT TSA, THE PATIENT EXPERIENCED RIGHT ASEPTIC GLENOID LOOSENING AND WAS REVISED. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. THE PATIENT HAS A HISTORY OF RTC TEAR AND REPAIR, HYPERTENSION, AND DIABETES. PATIENT WAS IN THE HOSPITAL FOR 1 DAY. DEVICES WILL NOT RETURN TO DUE TO STUDY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 11035670 ↗