Equinoxe 320-35-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885862534866), received between May 10, 2022 and Feb 26, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO HAD A LEFT RTSA, UNDERWENT A REVISION PROCEDURE DUE TO A LOOSE GLENOID. 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 PROVIDED. THE EXPLANTED DEVICE IS AVAILABLE FOR RETURN. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Aseptic loosening

  MAUDE report 24464173 ↗
• InjuryOct 28, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 4 YEARS AND 9 MONTHS POST THE INITIAL REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN AND STIFFNESS IN THEIR RIGHT SHOULDER. UPON EXAMINATION AND X-RAY IMAGING IT APPEARS THERE ARE CHANGES AROUND THE GLENOID IMPLANT, INDICATING BONE LOSS AND POSSIBLE LOOSENING OF THE GLENOID BASEPLATE IMPLANT. THERE ARE CHANGES AND BONE RESORPTION SHOWN AROUND THE HUMERAL STEM AS WELL. THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT TOTAL SHOULDER ARTHROPLASTY WITH REMOVAL OF IMPLANTS AND REIMPLANTATION OF A STABLE REVERSE CONSTRUCT. THE PATIENT WAS REVISED AND THE ORIGINAL HUMERAL TRAY, LINER, GLENOSPHERE, GLENOSPHERE SCREW, PERIPHERAL SCREWS AND CAPS, AND THE BASEPLATE WERE REMOVED. THE HUMERAL STEM WAS WELL FIXED AND WAS RETAINED. THE SHOULDER JOINT AND BONE WERE DEBRIDED AND PREPPED FOR RE-IMPLANT OF A COMPETITOR'S REVERSE GLENOID BASEPLATE AND GLENOSPHERE. AN EXACTECH HUMERAL TRAY AND LINER WERE IMPLANTED ON THE RETAINED STEM AND MATCHED TO THE SIZE OF THE COMPETITOR 36MM GLENOSPHERE. THE PATIENT LEFT THE OPERATING ROOM STABLE.

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

  MAUDE report 23403954 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE, DURING WHICH, THE PATIENT EXPERIENCED AN INTRAOPERATIVE FRACTURE OF THE ANTERIOR 1/3 OF THE GLENOID. THIS WAS RESOLVED WITH SURGICAL REPAIR, USING BOTH K-WIRE AND ULTIMATELY THE SCREWS ASSOCIATED WITH THE GLENOID BASEPLATE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 22555426 ↗
• InjuryApr 1, 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 TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. IT WAS ALSO NOTED BY THE PATIENT THAT THEY DEVELOPED PROGRESSIVELY WORSENING PAIN WITHOUT INCITING EVENT. AS A RESULT, APPROXIMATELY 3 YEARS AFTER INITIAL SHOULDER REPLACEMENT, THE PATIENT UNDERWENT A LEFT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Inadequate Osseointegration; Pain

  MAUDE report 21742444 ↗
• InjuryMar 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL RIGHT TSA, THE 80 Y/O FEMALE PATIENT PRESENTED BACK TO SURGEON'S OFFICE WITH COMPLAINTS OF PAIN AND DISSATISFACTION WITH THEIR RIGHT REVERSE TSA. UPON EXAMINATION AND IMAGING, THE SURGEON BELIEVED THE PATIENT'S GLENOID POSITIONING WAS TOO SUPERIOR, THIS LED TO INFERIOR SCAPULAR NOTCHING OF THE POLY LINER IMPLANT ONTO THE SCAPULAR BONE. EVIDENCE OF BONE REABSORPTION AND OSTEOLYSIS DUE TO POLY WEAR IS PRESENT. THE SURGEON FELT THE BASEPLATE IMPLANT WAS UNSTABLE AND LOOSE ON IMAGING. THE SURGEON WOULD LIKE IT REPORTED THAT THIS PATIENT OBTAINED A SCAPULAR SPINE FRACTURE AS WELL. THE PATIENT WAS SCHEDULED FOR A REVISION RIGHT REVERSE TSA SURGERY. DURING THE REVISION SURGERY, THE JOINT WAS EXPOSED. THE HUMERAL LINER, TORQUE SCREW, AND TRAY WERE REMOVED FROM THE STEM. THE STEM WAS CHECKED FOR STABILITY. THE GLENOID WAS THEN ACCESSED AND THE LOCKING SCREW AND GLENOSPHERE WERE REMOVED. THE LOCKING CAPS AND COMPRESSION SCREWS WERE REMOVED AND THE BASEPLATE SHOWED TO BE LOOSE IN THE GLENOID BONE. THERE WAS INFERIOR GLENOID BONE COMPLETELY MISSING DUE TO WEAR AND OSTEOLYSIS. CULTURES WERE TAKEN THROUGHOUT THE PROCEDURE. THE BASEPLATE WAS REM

  Patient problems: Bone Fracture(s); Osteolysis; Pain

  MAUDE report 21664935 ↗
• InjuryMar 17, 2025Unstable; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Osseointegration Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A MALE PATIENT, WHO HAD AN INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE, DATE UNKNOWN. THE PATIENT REPORTED LOOSENING OF THE IMPLANT OR INSTABILITY IN THEIR AFFECTED SHOULDER. THE PLAN WAS TO EXTRACT THE FX. STEM AND IMPLANT A LONG STEM, POSSIBLY USE HAT OR HRP. WHILE DOCTOR WAS EXPLANTING, THE HUMERAL SIDE, HE NOTICED LOOSENING OF THE GLENOID BASEPLATE AND EXTRACTED EVERYTHING. DR. DETERMINED THE JOINT WAS INFECTED AND USED A SPACER. A COMPETITOR¿S DEVICE WAS USED. 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 PROVIDED. IT IS UNKNOWN IF THE EXPLANTED DEVICES WILL BE MADE AVAILABLE AT THIS TIME AS IT IS CONTINGENT ON THE PATIENT¿S APPROVAL. DEVICE IMAGES WERE PROVIDED.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Medical device site infection; Septic loosening

  MAUDE report 21626169 ↗
• InjuryFeb 11, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 1 YEAR(S), 7 MONTH(S) AND 8 DAY(S) POST-OPERATIVE OF A REVISED RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING WITH PROGRESSIVELY WORSENING PAIN FOR 3 MONTHS WITHOUT INCITING EVENT. IN AN EARLIER REPORTED EVENT, 9 DAYS POST-OPERATIVE OF THE INITIAL IMPLANTATION, THE PATIENT UNDERWENT A 2-STAGE REVISION FOR GLENOID/CORACOID FRACTURE WHICH LOOSENED GLENOID. PATIENT DID NOT REPORT INJURY, BUT GLENOID COMPONENT WAS FOUND TO HAVE SHIFTED AT INITIAL POST-OP APPOINTMENT. THE PATIENT UNDERWENT RESECTION ARTHROPLASTY WITH EXPLANTATION OF ALL COMPONENTS INCLUDING THE TORQUE SCREW, PRESERVE STEM, 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 CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND DEFINITELY RELATED 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; Pain

  MAUDE report 21358748 ↗
• InjuryDec 30, 2024Migration; Migration

  IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED IN (B)(6) 2021, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 3 YEARS 7 MONTHS POST THE INITIAL PROCEDURE. TWO REVERSE SCREWS BROKE REQUIRING THE REVISION. THE GLENOID COMPONENTS, LINER, AND TRAY WERE REPLACED. NONE OF THE BROKE PIECES FELL INTO THE PATIENT WOUND SITE. 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 RETURN. THEY WERE SENT TO PATHOLOGY. NO DEVICE IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 21035048 ↗
• InjuryApr 11, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 70-YEAR-OLD WHITE FEMALE HAD A RIGHT TSA ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT EXPERIENCE ASEPTIC GLENOID LOOSENING. FELL POSTOP AND STARTED TO DEVELOP PAIN OVER TIME WITH GLENOID/HUMERAL LOOSENING PRESENT ON (B)(6) 2023 XR; NO BACTERIA GROWTH SO LIKELY ASEPTIC LOOSENING. THE PATIENT UNDERWENT THE ACTION OF STANDARD REVERSE W-PRESERVE STEM REVISION SURGERY ON (B)(6) 2024. THE PATIENT WAS REVISED TO NON-EXACTECH SPACER AND THE OUTCOME OF THIS EVENT IS CONSIDERED TO BE RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Aseptic loosening; Failure of Implant; Pain

  MAUDE report 19093927 ↗
• InjuryFeb 6, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE PATIENT HAD A LEFT RTSA ON (B)(6) 2020. A DIFFERENT SURGEON SCHEDULED A REVISION OF THE SHOULDER FOR (B)(6) 2024. BASED ON THE X-RAY IT LOOKED LIKE THE GLENOSPHERE BASEPLATE CAME LOOSE FROM THE GLENOID, AND ONE SCREW BROKE. THE SURGEON ENDED UP PUTTING IN AN ANTIBIOTIC SPACER AND PLANS TO REVISE IT BACK TO A REVERSE AT ANOTHER DATE. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18656151 ↗
• InjuryMay 23, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, APPROXIMATELY 3 MONTH POST OP INITIAL TSA, THIS 68 Y/O FEMALE PATIENT WAS REVISED DUE TO ASEPTIC GLENOID LOOSENING. PATIENT HAD A GLENOID GRAFT/COMPONENT LOOSENING. THE CASE REPORT FORM INDICATES THIS EVENT IS NOT RELATED TO DEVICES, BUT IS RELATED TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16987394 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1 YEAR POST OP THE INITIAL TSA, THIS (B)(6) MALE PATIENT'S WAS REVISED TO A REVERSE DUE TO INFECTION. PATIENT EXPERIENCED DEEP PAIN AFTER LIFTING A HEAVY SUITCASE IN 2021. NO IMPROVEMENT IN SYMPTOMS, LABS CONFIRMED INFECTION. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bacterial Infection

  MAUDE report 14345271 ↗