AEQUALIS REVERSED II DWD171Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03700386935954), received between Jul 17, 2020 and Sep 17, 2025 — classified as 9 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Loss of Osseointegration; Loss of Osseointegration

  A REVISION SURGERY WAS PERFORMED TO CONVERT FROM REVERSE SHOULDER TO HEMI DUE TO GLENOID COMPONENT BASEPLATE FAILURE AND SCAPULAR FRACTURE. THE GLENOID BASEPLATE/IMPLANTS BECAME LOOSE FOLLOWING INITIAL SURGERY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23077462 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION AFTER SHOULDER REPLACEMENT SURGERY. PAIN WAS ALSO REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22795120 ↗
• InjuryMar 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE AEQUALIS DEVICES WERE IMPLANTED TO THE PATIENT'S RIGHT SHOULDER. THE DEVICES WERE REMOVED BECAUSE THE PATIENT GOT AN INFECTION (MAYBE FROM KIDNEY) WHILE THE SURGEON THOUGHT THAT THE INFECTION WAS NOT CAUSED BY THE IMPLANT. BECAUSE THE PATIENT WAS QUITE ELDERLY, REVISION WAS NOT CONSIDERED, AND THE SURGERY WAS COMPLETED WITH A CEMENT MOLD CONTAINING ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 21631722 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT: (B)(6) - FLEX REVIVE STUDY. ADVERSE EVENT DETAIL: POST-OPERATIVE COMPLICATION: INCREASED PAIN AND STIFFNESS OF RIGHT SHOULDER. PATIENT HAS NO REDNESS OR SWELLING. ABNORMAL LABS (B)(6) 2024: CRP, ESR, CBC (HGB, HCT, RDW) AS WELL AS UNDERLYING DEGENERATIVE DISK DISEASE OF THE CERVICAL SPINE. TREATMENT/MEDICATION: PREDNISONE 5MG FOR 15 DAYS.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 19988606 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A POST OPERATIVE ADVERSE EVENT THAT INCLUDED SEVERE SHOULDER PAIN AND LOSS OF CONSCIOUSNESS THAT RESULTED IN THE FALL ONTO THE OPERATED SHOULDER AND LOSS OF MEMORY.

  Patient problems: Implant Pain; Loss of consciousness; Memory Loss/Impairment

  MAUDE report 15712539 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2020: ASCEND FLEX REVERSE SURGERY WAS PERFORMED. LATELY IN (B)(6) 2020: SIGNS OF INFECTION WERE FOUND AFTER THE SURGERY. (B)(6) 2021: REVISION SURGERY WAS PERFORMED. ALL THE IMPLANTS WERE REMOVED, THE AFFECTED PART WAS CLEANED, THE SPACER MADE BY CEMENT WAS IMPLANTED, AND THE SURGERY WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 12187707 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2020: ASCEND FLEX REVERSE SURGERY WAS PERFORMED. LATELY IN (B)(6) 2020: SIGNS OF INFECTION WERE FOUND AFTER THE SURGERY. (B)(6) 2021: REVISION SURGERY WAS PERFORMED. ALL THE IMPLANTS WERE REMOVED, THE AFFECTED PART WAS CLEANED, THE SPACER MADE BY CEMENT WAS IMPLANTED, AND THE SURGERY WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 11705806 ↗
• InjuryAug 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(6) 2018: INITIAL SURGERY OF ASCEND FLEX REVERSE WAS PERFORMED. (B)(6) 2020: THE BASEPLATE CAME OFF AND CAUSED DISLOCATION. (B)(6) 2020: REVISION SURGERY WAS PERFORMED WHICH WAS POSTPONED IN MID-(B)(6) 2020 . ALL THE IMPLANTS WERE REMOVED, AND THE ARROW BONE WAS FIXED INTO THE GLENOID WITH USING A SCREW, AND THE SURGERY WAS COMPLETED.

  Patient problems: Joint Dislocation

  MAUDE report 10402792 ↗
• InjuryJul 17, 2020Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth; Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  SINCE THIS PATIENT HAD A PROXIMAL HUMERAL FRACTURE, HE WAS USING AN ARTIFICIAL HEAD OF ANOTHER COMPANY'S PRODUCT (J & J) ONLY ON THE HUMERAL SIDE. DATE UNKNOWN: SINCE THE LOOSENING OF THE STEM IMPLANT AND THE GLENOID WERE WORN, ONLY THE ARTIFICIAL HEAD ON THE HUMERUS SIDE WAS REMOVED, AND CEMENT MOLDING WAS PLACED AT THE REMOVED PART. (B)(6) 2020: THE INITIAL SURGERY OF AEQUALIS REVERSE WAS PERFORMED. AFTER REMOVING THE J & J IMPLANT AND THE CEMENT MOLDING THAT HAD BEEN TEMPORARILY INSERTED, THE BONE GRAFT FROM THE HUMERAL HEAD WAS USED FOR THE GLENOID SIDE. (B)(6) 2020: A DISLOCATION OCCURRED. THE GLENOID IMPLANT CAME OFF FROM THE GLENOID. (B)(6) 2020: A REVISION SURGERY WAS PERFORMED. ON THE GLENOID SIDE, THE BONE GRAFT AND ALIGNMENT PINS WERE REORIENTED, AND THE BASE PLATE WAS REPLACED. DURING SURGERY, WHEN REPLACING THE GLENOID IMPLANT, THE STEM ON THE HUMERAL SIDE ALSO FELL OUT, SO THIS WAS ALSO REPLACED. THE THICKNESS AND ORIENTATION OF THE BONE GRAFT AND THE ORIENTATION OF THE ALIGNMENT PIN DID NOT FIT FIRMLY ON THE GLENOID IMPLANT, AND THIS IS CONSIDERED TO BE A TECHNICAL PROBLEM IN WHICH THE GLENOID IMPLANT HAD GONE UPWARD. THERE WAS NO PROBLEM AT THE DEVICE.

  Patient problems: Joint Dislocation; Joint Disorder

  MAUDE report 10288148 ↗