Equinoxe 320-31-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885862534972), received between Mar 30, 2022 and Mar 19, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED IN A CLINICAL STUDY THAT THE PATIENT PREVIOUSLY UNDERWENT AN INITIAL SHOULDER REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT DEVELOPED ASEPTIC GLENOID LOOSENING AND PAIN WITHOUT A KNOWN INCITING EVENT. NO MEDICAL OR SURGICAL INTERVENTION HAS BEEN UNDERTAKEN AT THIS TIME, AND THE PATIENT IS CURRENTLY UNDER OBSERVATION. THE DEVICE REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 24640738 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 9 MONTHS POST INITIAL OPERATION. THE REVISION WAS DUE TO AN INFECTION. SURGEON EXCHANGED THE LINER AND GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22216089 ↗
• InjuryJun 12, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF A RIGHT TOTAL SHOULDER REPLACEMENT 4 YEARS AND 4 MONTHS POST-OP DUE TO PAIN, POLY WEAR, AND INFECTION WITH CONTINUED TREATMENT WITH ANTIBIOTICS FOR 6 MONTHS POST-OP (CAPTURED ON A SEPARATE REPORT). SUBSEQUENTLY, THE PATIENT UNDERWENT AN ASPIRATION OF THE SHOULDER APPROXIMATELY 10 MONTHS AFTER THE REVISION PROCEDURE FOR CONTINUED PAIN AND FLUID ACCUMULATION (CAPTURED ON A SEPARATE REPORT). FOLLOWING THE ASPIRATION, CONTINUED PAIN WAS REPORTED AND AN MRI WAS OBTAINED WHICH SHOWED INFLAMMATION AROUND THE IMPLANT. APPROXIMATELY 1 MONTH LATER, THE PATIENT UNDERWENT A REVISION OF THE RIGHT TOTAL SHOULDER. INTRAOPERATIVELY, SEROSANGUINEOUS FLUID WAS NOTED AND INTRAOPERATIVE CULTURES WERE ALL NEGATIVE. FURTHER, THE SURGICAL PATHOLOGY REPORT NOTED A SOFT TISSUE REACTION TO POLYETHYLENE PARTICULATE DEBRIS. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM. THE PATIENT WAS FOLLOWED BY THE PAIN MANAGEMENT SERVICE POST-OPERATIVELY AND WAS DISCHARGED HOME APPROXIMATELY 7 DAYS LATER. THE PATIENT WAS NOTED TO BE DOING WELL AT HIS 1 WEEK POST-OPERATIVE VISIT.

  Patient problems: Inflammation; Joint effusion; Metal Related Pathology; Muscle/Tendon Damage; Osteolysis; Pain

  MAUDE report 22195647 ↗
• InjuryJun 12, 2024Naturally Worn; Naturally Worn

  THIS EVENT WAS RECEIVED THROUGH MEDWATCH REPORT # (B)(4). PATIENT UNDERWENT RIGHT REVERSE TOTAL SHOULDER REPLACEMENT AND RIGHT SHOULDER BICEPS TENODESIS FOR RIGHT SHOULDER ROTATOR CUFF TEAR ARTHROPATHY AND BICEPS TENOSYNOVITIS ON (B)(6) 2021. HE WAS DISCHARGED HOME ON (B)(6) 2021. THE PATIENT WAS PROGRESSING WITH RECOVERY AND DOING WELL AS OF 04-MAY-2021. HE CAME FOR AN OFFICE VISIT ON 09-JAN-2024 (LAST VISIT WAS 04- MAY-2021), AT WHICH TIME THE PATIENT REPORTED OVER THE PAST YEAR OR SO, SOME CLICKING AND DECREASE IN HIS FUNCTION. 09-JAN-2024 X-RAYS OF THE RIGHT SHOULDER WERE REVIEWED, DEMONSTRATING REVERSE TSA IN PLACE, WITH SOME OSTEOLYSIS AROUND THE GLENOID, BUT NO OBVIOUS GROSS LOOSENING OF THE BASEPLATE; THERE APPEARED TO BE DISPLACEMENT OF THE POLYETHYLENE LINER. DIAGNOSTIC WORKUP INCLUDING CT SCAN, CBC, ESR, CRP, AND AN ASPIRATION WERE RECOMMENDED. THE CULTURES WERE NEGATIVE AND CT CONFIRMED FAILURE OF THE POLYETHYLENE LINER WITH DISSOCIATION. THE PATIENT WAS INDICATED FOR REVISION TOTAL SHOULDER ARTHROPLASTY. THE PATIENT OPTED TO HAVE THE REVISION SURGERY CLOSER TO WHERE HE LIVES IN ANOTHER STATE. ON (B)(6) 2024 THE PATIENT UNDERWENT REVISION OF FAILED REVERSE ARTHROPLASTY,

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant; Metal Related Pathology; Osteolysis

  MAUDE report 19521955 ↗
• InjuryOct 5, 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 LEFT TSA, THIS 71 Y/O FEMALE PATIENT WAS REVISED DUE TO STATING SHOULDER FEELING LIKE IT WAS LOOSE. THERE WERE NO REPORTED ISSUED DURING THE SURGICAL REVISION. THE PATIENT WAS REVISED AND DEEMED TO BE STABLE. THE DEVICE WAS NOT RETURNED DUE TO HOSPITAL POLICY. NEW INFORMATION ON 27 SEP 2022: THE PATIENT HAD JOINT LAXITY. NO COMPONENTS WERE LOOSE. NO ADDITIONAL INFORMATION.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15546312 ↗
• InjurySep 30, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED, DURING LEFT SHOULDER REVISION SURGERY, THE SURGEON REMOVED A LOOSE BODY/OSTEOPHYTE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE DEVICE IS NOT RETURNING DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 15514788 ↗
• InjuryMar 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, POST OP SHOULDER SURGERY, THIS (B)(6) PATIENT REPORTED INSTABILITY AND SUBLUXATION. THE PATIENT HAS HAD ROUGHLY 6 SUBLUXATION EPISODES. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND DEFINITELY NOT RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. REVISION HAS NOT OCCURRED, CONTINUING DELTOID STRENGTHENING EXERCISES. OUTCOME IS CONTINUING.

  Patient problems: Constipation

  MAUDE report 13949248 ↗