Equinoxe 320-06-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862563699), received between Feb 16, 2022 and Aug 8, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE AND WAS IMPLANTED WITH EXACTECH DEVICES. SUBSEQUENTLY, THE PATIENT EXPERIENCED A DISLOCATION. PATIENT HAD SPINE SURGERY AND HAS HAD SHOULDER PAIN SINCE. PHYSICAL THERAPY WAS ORDERED FOR STRENGTHENING EXERCISES. SHOULDER BECAME EASILY AGGRAVATED, SO CT ORDERED. CT COMPLETED SHOWING DISLOCATION. X-RAYS DONE CONFIRMING DISLOCATION W/ POSSIBLE DISSOCIATION OF POLYETHYLENE LINER FROM HUMERAL TRAY DURING PATIENT OFFICE VISIT. AS A RESULT, APPROXIMATELY 1 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: Implant Pain; Joint Dislocation; Metal Related Pathology; Solid Tumor

  MAUDE report 22756482 ↗
• InjuryJun 10, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A 68 YO MALE PATIENT, WHO HAD A LEFT SHOULDER IMPLANTED, UNDERWENT A PROCEDURE. IT APPEARED THE HUMERAL LINER WAS DISSOCIATED FROM THE HUMERAL PLATE. THE SURGEON BELIEVED THAT THE POLY HAD BEEN DISSOCIATED FOR QUITE SOME TIME PER THE X-RAYS. THE PATIENT HAD SIGNIFICANT METALLOSIS THROUGHOUT THE JOINT. BOTH THE HUMERAL STEM AND GLENOID BASEPLATE WERE LOOSE. THEY WERE REMOVED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. PATIENT WILL BE REVISED AT A LATER DATE WITH A CUSTOM 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. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICY. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 5 REPORTS FOR THIS EVENT. THIS IS THE 2ND OF 2 EVENTS FOR THIS PATIENT.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 22179230 ↗
• InjuryDec 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 1 MONTH POST INITIAL RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA), THE PATIENT UNDERWENT REVISION OF THE PROSTHESIS DUE TO DISLOCATION. THE PATIENT WAS WHEELCHAIR-BOUND AND WITHIN THE FIRST COUPLE WEEKS AFTER IMPLANT, REACHED OVER A CHAIR AND DISLOCATED THE PROSTHESIS. THE SURGEON PROCEEDED TO REVISE THE PATIENT TO LARGER AND CONSTRAINED IMPLANTS. THE GLENOSPHERE, LOCKING SCREW, AND LINER WERE SWAPPED OUT. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE. THERE WAS A SURGICAL DELAY/PROLONGATION OF APPROXIMATELY 30-45 MINUTES IN RELATION TO THE NEED FOR REVISION SURGERY DUE TO THE DISLOCATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 20822738 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY THREE YEARS POST INITIAL LEFT TSA, THE 67 MALE Y/O PATIENT HAD A SINGLE STAGE REVISION FOR INFECTION. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF THE DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 19369608 ↗
• InjuryOct 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON AN UNKNOWN DATE. A CONVERSION OF ANATOMIC TO REVERSE OCCURRED ON (B)(6) 2023. 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 17873791 ↗
• InjuryFeb 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2022. THE STEM, POLY AND TRAY WERE REVISED ON (B)(6) 2023 DUE TO TOTAL SHOULDER DISLOCATION. THERE WAS NO REPORTED BREAKAGE OF DEVICES OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 16293307 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 65 YO MALE PATIENT, HAD AN INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6)2021, AND THEN UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 1 YEAR 4 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD A SUSPECTED INFECTION. I&D WAS DONE AND LINER AND GLENOSPHERE WERE REPLACED. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION DURING THE REVISION PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE DEVICES WILL NOT TO BE RETURNED DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 16195962 ↗
• InjuryFeb 16, 2022Fracture; Fracture

  A REPORTED, DURING THE PRIMARY IMPLANT PROCEDURE OF THE R SHOULDER, THIS (B)(6) FEMALE PATIENT EXPERIENCED A CORACOID TIP FRACTURE. SURGEON PERFORMED A SUTURE FIXATION. GPS WAS USED DURING THIS CASE, HOWEVER IT IS UNKNOWN WHERE THE GPS PATIENT TRACKER WAS ATTACHED. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND/OR PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

  Patient problems: Bone Fracture(s)

  MAUDE report 13541778 ↗