Equinoxe 300-01-17Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862079343), received between Jun 8, 2022 and Oct 28, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 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 TSA (TOTAL SHOULDER ARTHROPLASTY) ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INSTABILITY (CAPTURED IN 1038671-2025-03177). THEN APPROXIMATELY 9 MONTHS LATER, THEY EXPERIENCED ASEPTIC HUMERAL LOOSENING. THE PATIENT CAME INTO THE CLINIC WITH PAIN AND ARM SWELLING. THEY WERE GIVEN A SARMIENTO BRACE AND PAIN MEDICATION. THE DEVICE REMAINS IMPLANTED. THE OUTCOME IS CONSIDERED RESOLVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Aseptic loosening; Pain; Swelling/ Edema

  MAUDE report 23402633 ↗
• InjurySep 10, 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 REVERSE TOTAL SHOULDER REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED A HUMERAL FRACTURE. REPORTEDLY, THE PATIENT HAD BEEN DOING WELL UNTIL 3 WEEKS AGO: STARTED EXPERIENCING PAIN AND LOSS OF ROM/FUNCTION WITHOUT ANY TRAUMA. AS A RESULT, APPROXIMATELY 14 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT WAS PLACED IN AN ORTHOPEDIC BRACE. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Loss of Range of Motion; Pain

  MAUDE report 23014444 ↗
• InjuryAug 26, 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 RIGHT SIDE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE. IT WAS REPORTED THAT THE GLENOID WAS COMPLETELY ERODED AND CAME OUT IN FRAGMENTS. ALL PIECES OF THE IMPLANT THAT REMAINED WERE REMOVED AND THE AREA WAS THOROUGHLY DEBRIDED. THE SURGEON HAD CONSIDERED KEEPING THE STEM, BUT UPON INSPECTION IT WAS LOOSE AND CAME OUT WITH MINIMAL EFFORT. THE PATIENT WAS REVISED TO A COMPETITOR'S DEVICES. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES AND X-RAYS WERE PROVIDED. NO DEVICES WERE NOT RETURNED FOR EVALUATION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22898986 ↗
• InjuryOct 30, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 1 MONTH(S) AND 10 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION. THE PATIENT UNDERWENT STANDARD REVERSE AND WAS REVISED WITH EXACTECH DEVICES. THE PATIENT'S BONE QUALITY WAS NOT OPTIMAL AS THEY NEEDED TO CEMENT A 17 STEM. IT WAS FURTHER NOTED THAT DUE TO THE INFECTION, INCISION AND DRAINAGE WAS NEEDED AND THE STEM WAS FOUND TO BE LOOSE AFTER THE TRAY AND LINER WERE REMOVED. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER ISSUES OR COMPLICATIONS WERE REPORTED AND THE DEVICES WILL NOT BE RETURNING FOR EVALUATION DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 20570412 ↗
• 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 7 YEARS POST OP THE INITIAL TSA, THIS 51 Y/O FEMALE PATIENT'S WAS REVISED TO A STANDARD REVERSE DUE TO ASEPTIC HUMERAL LOOSENING. PATIENT HAD PERIPROSTHETIC PAIN, NEGATIVE FOR INFECTION, AND SURGEON PLANNED AB SPACER PLACEMENT. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Failure of Implant

  MAUDE report 14631732 ↗