Equinoxe 320-31-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885862534934), received between Jan 16, 2020 and Dec 27, 2024 — classified as 14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2024Unintended Collision; Insufficient Device Problem Information; Unintended Collision; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 58 YO PATIENT, INITIAL RIGHT SHOULDER IMPLANTED IN (B)(6) 2021, UNDERWENT A REVISION PROCEDURE IN (B)(6) 2024, APPROXIMATELY 3 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH HUMERAL PAIN. A CT REVEALED SOME IMPINGEMENT ON THE INFERIOR GLENOID. THE SURGEON REMOVED GLENOID AND FOLLOWING TRIALING, IMPLANTED A 36 EXPANDED GLENOID. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE AVAILABLE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISCARDED. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

  Patient problems: Joint Impingement; Pain

  MAUDE report 21029967 ↗
• InjuryJun 19, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED, PRIOR TO USE AND DURING SET-UP, WHILE THE NURSE WAS OPENING THE STERILE PACKAGING, THEY NOTICED A HAIR INSIDE THE PACKAGE. THE PHYSICIAN HAD TO GRAB AND OPEN ANOTHER GLENOSPHERE. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570616 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 63-YEAR-OLD NON-HISPANIC WHITE FEMALE HAD A RIGHT TSA ON (B)(6) 2022. THE PATIENT PRESENTED WITH SUB-ACROMIAL IMPINGEMENT ON (B)(6) 2023. PATIENT NOTICED INCREASED PAIN WITH OVERHEAD ACTIVITY WITHOUT INCITING EVENT. THE EVENT REPORTED A REVISION WITH NO DATE AND THE OUTCOME IS CONSIDERED CONTINUING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

  Patient problems: Pain

  MAUDE report 19218099 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS FEMALE PATIENT HAD A LEFT SHOULDER REVISION SURGERY ON (B)(6) 2023 DUE TO DISLOCATION THAT OCCURRED PRIOR TO A FALL/POST TRAUMATIC EVENT. POST REVISION HRP REVERSE TSA SURGERY, THE PATIENT RETURNED TO SURGEONS OFFICE FOR FOLLOW-UP. IMAGING WAS TAKEN AT THE FOLLOW-UP POST-REVISION SURGERY AND IT SHOWED EARLY SCAPULAR NOTCHING WITH BONE CHANGES BEHIND THE GLENOID IMPLANT. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Failure of Implant

  MAUDE report 18083013 ↗
• InjuryOct 2, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2020. THE PATIENT PRESENTED ON (B)(6) 2020 AND HAD ACROMIAL FRACTURE TYPE 1. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE, POSSIBLY RELATED TO PROCEDURE. OUTCOME: RESOLVED ON (B)(6)2021.

  Patient problems: Bone Fracture(s); Periprosthetic fracture

  MAUDE report 17850223 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 10 MONTHS POST OP INITIAL RIGHT TSA, THIS 73 Y/O FEMALE PATIENT WAS REVISED DUE TO PAIN. LATERALISED GLENOSPHERE TO REDUCE IMPINGEMENT PAIN. LINER HAD TO BE REMOVED TO GAIN ACCESS TO GLENOSPHERE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING - DISCARDED BY HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 17144817 ↗
• InjuryApr 3, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 61 YO FEMALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2023, WAS REVISED ON (B)(6) 2023. THE REASON FOR THE REVISION WAS NOT REPORTED. THERE WAS A LESS THAN 30 SECOND DELAY DURING THE PROCEDURE WITH NO PATIENT IMPACT AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 16668415 ↗
• InjuryOct 24, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE EQUINOXE SHOULDER STUDY, APPROXIMATELY THREE YEARS POST INITIAL TSA, THE 71 Y/O FEMALE PATIENT WAS SITTING ON HER COUCH WHEN HER SHOULDER DISLOCATED WHILE TRYING TO STAND UP. PATIENT HAD A REVISION ON (B)(6) 2022 FOR A STANDARD REVERSE. PER CLINICAL STUDY CASE REPORT THE EVENT IS DEFINITELY RELATED TO THE DEVICE AND TO THE PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 15657998 ↗
• InjuryJul 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 66 YO FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2022, REPORTED FEELING A POP WHILE DOING PHYSICAL THERAPY PENDULUM EXERCISES 5 MONTHS POST OP, AND HAD REVISION SURGERY ON (B)(6) 2022. THE SURGEON REMOVED THE GLENOID COMPONENT AND CONVERTED THE HUMERAL COMPONENT INTO A HEMI. HE BONE GRAFTED THE GLENOID WITH DISTAL CLAVICLE AND WILL COME BACK IN TO REVISE BACK TO REVERSE AFTER THE GLENOID HEALS. DEVICES ARE AVAILABLE FOR RETURN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107977 ↗
• InjuryMar 30, 2022Fracture; Fracture

  AS REPORTED, APPROXIMATELY 1 YEAR POST OP INITIAL SHOULDER SURGERY, THIS (B)(6) FEMALE PATIENT PRESENTED A TRAUMATIC ACROMIAL FRACTURE AND UNDERWENT AN ACROMIONECTOMY ON (B)(6) 2021. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND DEFINITELY NOT RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. OUTCOME WAS CONSIDERED RESOLVED ON (B)(6) 2022.

  Patient problems: Bone Fracture(s)

  MAUDE report 13949178 ↗
• InjuryMar 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 2 YEARS POST OF SHOULDER SURGERY, THIS (B)(6) FEMALE PATIENT REPORTED INSTABILITY AND 2 SUBLUXATIONS FROM REACHING BEHIND HER CAR SEAT TO LIFT HER SMALL DOG. 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: Joint Dislocation

  MAUDE report 13949126 ↗
• InjuryDec 21, 2021Fracture; Fracture

  AS REPORTED, APPROXIMATELY 10 MONTHS POSTOP THE PRIMARY L TSA, THIS (B)(6) FEMALE PRESENTED WITH A SUDDEN ONSET OF PAIN WITHOUT AN INCITING EVENT. CLINICAL SCAPULAR SPINE FRACTURE WAS NOT VISUALIZED ON X-RAY. THE PATIENT HAS A PRE-OP HISTORY OF AVASCULAR NECROSIS OF HUMERAL HEAD. THE REPORTED ACTION TAKEN WAS TO WEAR A SLING AND RELATIVE REST. OUTCOME REPORTED AS RESOLVED ON (B)(6) 2021. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. DEVICES WILL NOT RETURN DUE TO STUDY POLICY.

  Patient problems: Bone Fracture(s)

  MAUDE report 13052856 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THIS (B)(6) Y/O FEMALE PATIENT PRESENTED WITH RIGHT SHOULDER PAIN. A REVISION WAS SCHEDULED. THE SURGEON REMOVED THE HUMERAL TRAY, LINER AND GLENOSPHERE. HE REPLACED THEM WITH A 40+4 GLENOSPHERE, NEUTRAL LINER AND A +10 HUMERAL TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN DUE TO FACILITY POLICY.

  Patient problems: Failure of Implant

  MAUDE report 12868089 ↗
• InjuryJan 16, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED, THE (B)(6) FEMALE PATIENT HAS A HISTORY OF ROTATOR CUFF REPAIR, PRIMARY GLENOHUMERAL ARTHROSIS, HYPERTENSION, AND HYPERTHYROIDISM. THIS PATIENT¿S INITIAL LEFT TSA OF THE WAS ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2019 DUE TO SEPTIC LOOSENING. THE DEVICES WILL NOT BE RETURNED. THE STUDY DATABASE INDICATES THE EVENT IS RESOLVED. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 9595892 ↗