Equinoxe 320-06-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885862563712), received between Nov 24, 2021 and Sep 29, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Naturally Worn” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Naturally Worn

  As reported, the patient underwent an initial total shoulder arthroplasty. Approximately 4 months post the first revision surgery, the patient underwent another revision due to liner disassociation due to the patient "falling". All implants were removed and replaced with competitor products. There was no reported breakage of device or surgical delay/prolongation.

  Patient problems: Fall

  MAUDE report 50936311 ↗
• InjurySep 14, 2026Naturally Worn

  It was reported that this patient underwent a left shoulder replacement. Subsequently, the patient experienced pain. Upon evaluation, the polyethylene component was found to be dislodged. The patient underwent revision surgery to address the dislodged polyethylene component. The patient was last known to be in stable condition following the event. No further information is available.

  Patient problems: Pain

  MAUDE report 50754636 ↗
• InjuryJun 1, 2026Unstable; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT A PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS UNSTABLE AND WAS DISLOCATING REQUIRING THE REVISION TO REGAIN THEIR JOINT STABILITY. DURING THE SURGERY, THERE WERE CLEAR SIGNS OF METALLOSIS AND BLACK TISSUE. THE POLY WAS EASILY REMOVED, AND THE SURGEON STATED THAT THE POLY WASN'T REALLY LOCKED INTO THE HUMERAL TRAY BUT WAS JUST SITTING ON TOP OF IT. THE SURGEON REMOVED THE 42MM +2.5 POLY AND THE +0 HUMERAL TRAY AND TORQUE SCREW AS WELL AS THE 42MM GLENOSPHERE AND GLENOSPHERE LOCKING SCREW. THE SURGEON KEPT THE 7MM PRESERVE STEM IMPLANTED AS IT WAS WELL FIXED AND ALSO KEPT THE GLENOID BASEPLATE IMPLANTED AND THE 3 PERIPHERAL SCREWS. TO INCREASE JOINT STABILITY, THE SURGEON RE-IMPLANTED A 42MM +4 LAT. GLENOSPHERE AND LOCKING SCREW ON THE GLENOID SIDE AND ON THE HUMERAL SIDE, HE IMPLANTED A +5MM HUMERAL TRAY AND TORQUE SCREW WITH A 42MM +0 CONSTRAINED LINER. THE PATIENT WAS STABLE WITH THESE IMPLANTS. 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. THE HOSPITAL W

  Patient problems: Joint Dislocation; Joint Laxity; Metal Related Pathology

  MAUDE report 25356208 ↗
• InjuryJun 2, 2025Naturally Worn; Naturally Worn

  AS REPORTED, APPROXIMATELY 3.5 YEARS POST INITIAL LEFT TSA, THE PATIENT EXPERIENCED POLY DISASSOCIATION. PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology

  MAUDE report 22122163 ↗
• InjuryDec 2, 2024Unstable; Device Dislodged or Dislocated; Naturally Worn; Unstable; Device Dislodged or Dislocated; Naturally Worn

  AS REPORTED, APPROXIMATELY 3 YEARS AND 1 MONTHS FOLLOWING A REVISION OF THE RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA), ANOTHER REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE PATIENT'S SHOULDER AT SOME POINT BECAME UNSTABLE AGAIN AND DISLOCATED. DURING THE REVISION SURGERY, THE LINER WAS FOUND TO HAVE DISSOCIATED FROM THE TRAY AND WAS NO LONGER BETWEEN THE TRAY AND SPHERE. METALLOSIS IN THE TISSUE WAS OBSERVED, AS WELL AS WEAR ON THE LINER, TRAY AND SPHERE. THE GLENOSPHERE, LOCKING SCREW, LINER, REVERSE TORQUE SCREW, AND TRAY WERE SWAPPED OUT AND THE PATIENT WAS UPSIZED TO A 46 EXPANDED GLENOSPHERE, 0MM 46MM CONSTRAINED LINER AND 5MM TRAY. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE. THE EVENT LEAD TO A SURGICAL DELAY/PROLONGATION OF APPROXIMATELY 30-45 MINUTES. THE DELAY/PROLONGATION WAS IN REFERENCE TO THE NEED FOR REVISION SURGERY DUE TO DISLOCATION OF THE PROSTHESIS AND DISSOCIATION OF THE POLY. THERE WAS AN ADVERSE EVENT OF METAL-ON-METAL WEAR OF THE GLENOSPHERE AND TRAY AND THE ASSOCIATED METALLOSIS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Joint Dislocation; Joint Laxity; Metal Related Pathology

  MAUDE report 20824015 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  APPROXIMATELY 1 YEAR(S), 8 MONTH(S) AND 5 DAY(S) POST-OPERATIVE OF A LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING WITH SHOULDER PAIN AND INFECTION. APPROXIMATELY 3 MONTHS FOLLOWING THE ONSET OF SYMPTOMS, THE PATIENT RECEIVED A STEROID INJECTION AND ASPIRATION. THE OUTCOME OF THIS EVENT IS CONSIDERED CONTINUING, AND THE CLINICAL REPORT INDICATES THAT THE EVENT IS POSSIBLY RELATED TO THE DEVICE(S) OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20654024 ↗
• InjuryOct 11, 2024Naturally Worn; Naturally Worn

  AS REPORTED, THE PATIENT FELT A POP AND THE POLY DISSOCIATED ON THE RIGHT SIDE AND HAD TO BE REVISED. A NEW POLY AND GLENOSPHERE WERE IMPLANTED DUE TO METAL DEBRIS. ALL FRAGMENTS, PARTS AND PIECES WERE REMOVED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Metal Related Pathology

  MAUDE report 20432037 ↗
• InjurySep 9, 2022Unstable; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Unstable; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2022. THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INSTABILITY. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS NOT RETURNING AS IT IS AGAINST HOSPITAL POLICY.

  Patient problems: Failure of Implant; Joint Dislocation; Joint Laxity

  MAUDE report 15390547 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA CLINICAL STUDY, EQUINOXE SHOULDER STUDY, THAT A 69 YO CAUCASIAN FEMALE, HEIGHT 70 IN., WEIGHT 177 LBS., BMI 25, WHO WAS INITIALLY IMPLANTED ON THE LEFT SIDE ON (B)(6) 2021 FOR A PREOPERATIVE DIAGNOSIS OF OSTEOARTHRITIS REPORTED THEY FELT POPPING WHILE THEY SLEPT. THERE WERE NO SYMPTOMS NOTED ON X-RAY. SCAPULAR SPINE FRACTURE, (TYPE 2). DATE OF ONSET (B)(6) 2021. NO MEDICATION, REVISION, OR OTHER ACTIONS TAKEN. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. OUTCOME REPORTED RESOLVED ON (B)(6) 2021. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SCAPULAR SPINE FRACTURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND POSSIBLY RELATED TO SURGICAL PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 15260482 ↗
• InjuryNov 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THIS 69 Y/O MALE PATIENT¿S INCURRED 2 RIGHT SHOULDER ANTERIOR DISLOCATIONS. THE PATIENT WAS SCHEDULED FOR A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PATIENT¿S OUTCOME IS REPORTED AS RESOLVED. ALL INFORMATION RECEIVED FROM A CLINICAL STUDY DATABASE. 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: Joint Dislocation

  MAUDE report 12868297 ↗