Equinoxe 320-02-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862186768), received between May 22, 2019 and Oct 15, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

• InjuryOct 15, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED THE DISASSEMBLY AND MIGRATION OF THE POLYETHYLENE COMPONENT. AS A RESULT, APPROXIMATELY 2 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT UNDERWENT A RIGHT SHOULDER REVISION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 23291268 ↗
• InjuryJun 9, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT NOTICED THE SHOULDER FELT DIFFERENT IN THE PAST MONTH. IT IS UNKNOWN IF THE PATIENT EXPERIENCED AN INJURY OR FALL PRIOR. IMAGING REVEALED THE HUMERAL LINER HAD DISSOCIATED AND WAS NO LONGER SITTING IN THE TRAY. THE SHOULDER WAS STILL REDUCED, WITH THE TRAY ARTICULATING WITH THE GLENOSPHERE. IT IS UNKNOWN HOW LONG THE HUMERAL LINER HAD BEEN DISSOCIATED. AS A RESULT, APPROXIMATELY 5 YEARS AND 6 MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. THE HUMERAL STEM WAS FOUND TO BE WELL FIXED AND WAS RETAINED. THE HUMERAL LINER HAD MIGRATED POSTERIOR TO THE GLENOSPHERE, AS DISCOVERED FOLLOWING REMOVAL OF THE GLENOSPHERE. THE AREA WAS EXTENSIVELY DEBRIDED AND IRRIGATED WITH ANTIMICROBIAL WOUND SOLUTION AND SALINE. TISSUE CULTURES WERE TAKEN DUE TO OBSERVATION OF METALLOSIS, THERE WAS NO EVIDENCE OF INFECTION. 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. THIS IS REPORT 3 OF 3 FOR THIS EVENT/PATIENT.

  Patient problems: Metal Related Pathology

  MAUDE report 22169301 ↗
• InjuryFeb 10, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 5 YEARS AND 9 MONTHS POST INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY (TSA) FOR SECONDARY ARTHRITIS AND A MASSIVE ROTATOR CUFF TEAR AND APPROXIMATELY 2 YEARS AND 5 MONTHS POST REVISION FOR PROSTHETIC DISLOCATION CAUSED BY DISASSEMBLY OF THE POLYETHYLENE INSERT, A SECOND REVISION WAS PERFORMED DUE TO PAIN REPORTED BY THE PATIENT AT WHICH TIME THE GLENOSPHERE, HUMERAL LINER, AND HUMERAL ADAPTER TRAY WERE REPLACED. THE HUMERAL LINER WAS CHANGED TO A CONSTRAINED HUMERAL LINER. DESPITE THE REVISIONS, THE INSERT CONTINUED TO DISASSEMBLE, AND THE INNER JOINT EXHIBITED AN UNUSUAL BROWNISH DISCOLORATION INDICATING METALLOSIS. EVENT AND PATIENT OUTCOME WERE NOT PROVIDED. PRODUCTS RETURNED.

  Patient problems: Joint Dislocation; Metal Related Pathology; Pain

  MAUDE report 21344621 ↗
• InjuryNov 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 28 WEEKS POST INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY (TSA), THE SHOULDER DISLOCATED WHILE THE PATIENT WAS ON HOLIDAYS AND AS A RESULT BECAME INFECTED. A REVISION WAS PERFORMED AT WHICH TIME THE SURGEON PUT A LARGER GLENOSPHERE AND PERFORMED A WASH OUT. 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.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 20799371 ↗
• InjuryJan 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THIS (B)(6) MALE PATIENT REQUIRED A REVISION ABOUT 5 MONTHS POST OP DUE TO DISLOCATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNING.

  Patient problems: Joint Dislocation

  MAUDE report 13333699 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 26 MONTHS AFTER THE INITIAL IMPLANT, THIS (B)(6) Y/O MALE PATIENT PRESENTED TO SURGEON WITH SOME SHOULDER INSTABILITY IN THEIR REVERSE SHOULDER AFTER OVER A YEAR OF GOOD FUNCTION AND STABILITY. SURGEON WAS ABLE TO DISLOCATE IN OFFICE AND ELECTED TO UPSIDE COMPONENTS SURGICALLY TO ACHIEVE STABILITY. SURGEON UPSIZED THE 42MM GLENOSPHERE TO A 46MM. ALSO REMOVED A 42 X 2.5MM LINER AND REPLACED WITH A 46 X 2.5MM CONSTRAINED LINER. SURGEON EXPECTS A GREAT OUTCOME AND PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. DEVICES WILL NOT RETURN DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 10199548 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 1.5 YEARS POSTOP THE INITIAL IMPLANT, THIS 66 Y/O MALE PATIENT WAS REVISED IN (B)(6) 2019. REASON FOR REVISION WAS NOT REPORTED. EVENT DISCOVERED IN A RECENT COMPLAINT. DEVICES ARE NOT RETURNING. NO OTHER INFORMATION IS PATIENT CONDITIONS.

  Patient problems: No Information

  MAUDE report 9340392 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD HIS PRIMARY SURGERY IN OF (B)(6) 2019, THEN HE WAS DISLOCATING SO THE DOCTOR REVISED HIM. HE PULLED OUT THE STEM, TRAY, AND LINER. HE ALSO REPLACED THE GLENOSPHERE. THE +10 TRAY DISASSOCIATED FROM THE STEM. THE SCREW ON THE DISASSOCIATED TRAY WAS NOT BROKEN OR STRIPPED.

  Patient problems: Joint Dislocation

  MAUDE report 9328136 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem

  DOCTOR REVISED THE SHOULDER BUT BASED ON THE BONE LOSS, ORIGINAL POSITIONING OF THE IMPLANT, AND POTENTIAL INFECTION HE WAS UNABLE TO REPAIR THE DAMAGE. NO IMPLANTS WERE PLACED IN THE PATIENT.

  Patient problems: Osteolysis

  MAUDE report 8767837 ↗
• InjuryMay 22, 2019Device Dislodged or Dislocated

  REVISION PERFORMED ON (B)(6) 2019. THIS SHOULDER WAS DISLOCATING DUE TO CALCIFICATION OF THE DELTOID WHICH KEPT PUSHING THE HUMERUS ANTERIOR AND DISLOCATING THE SHOULDER.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 8633198 ↗