AEQUALIS REVERSED II DWD195Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03700386935930), received between Jul 26, 2016 and Feb 26, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT SADLY HAD AN ALCOHOL PROBLEM HENCE THE MANY FALLS LEADING TO DISLOCATIONS, NOT COMPLIANT WITH REHAB AND MORE LIKELY TO INFECT. THIS IS THE FOURTH REVISION OF THE SPACER, LINER AND GLENOSPHERE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Fall; Subluxation

  MAUDE report 24458228 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE REVISION OF LINER, SPACER AND GLENOSPHERE WAS DONE DUE TO INFECTION THAT SPREAD FROM ANOTHER JOINT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 24080390 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY INCLUDING THE REMOVAL OF GLENOID IMPLANTS AND POLY LINER IN NEEDED DUE TO INFECTION. IT WAS ALSO REPORTED BY THE FACILITY THAT THE INFECTION HAD NOTHING TO DO WITH THE PRODUCT OR STERILITY OF THE PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 22374561 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN DECEMBER 2013 ¿ FEBRUARY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s)

  MAUDE report 21533753 ↗
• MalfunctionAug 26, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT IS REPORTED THAT IT WAS IMPOSSIBLE TO SCREW THE GLENOID BASE WHEN IMPACTING GLENOSPHERE. THE GLENOSPHERE HAS BEEN REPLACED BY ONE LESS SUITED TO THE PATIENT'S CASE. IT MAY INCREASED RISK OF INFECTION AND LOSS OF POSTOPERATIVE RECOVERY."

  Patient problems: Insufficient Information

  MAUDE report 20064618 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION AS A POST-OPERATIVE COMPLICATION. THE PATIENT REPORTS HAVING PAIN. THE PATIENT UNDERWENT A RE-OPERATION WITH COMPONENT CHANGE.

  Patient problems: Implant Pain; Post Operative Wound Infection

  MAUDE report 13634797 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STRYKER REPRESENTATIVE CONTACTED COMPLAINT HANDLING TEAM AND REPORTED THE FOLLOWING ISSUE: "PATIENT (B)(6) UNDERWENT A REVISION SURGERY DUE TO DEEP INFECTION. REMOVAL OF AEQUALIS ASCEND FLEX HUMERAL COMPONENTS (STEM AND INSERT) AND AEQUALIS REVERSED GLENOID SPHERE." 1ST REVISION SURGERY.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 13523761 ↗
• InjuryMar 7, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT IS FACING AN INSTABILITY-DISLOCATION. PATIENT DISLOCATED SHOULDER AND HAS HAD ISSUES WITH INSTABILITY SINCE. X-RAYS SHOW BROKEN INFERIOR SCREW ON GLENOID. PATIENT UNDERWENT A REVISION SURGERY TO FIX INSTABILITY ISSUES. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7319964 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR BREAKAGE OF TWO OF THE PERIPHERAL LOCKING SCREWS OF THE BASEPLATE DUE TO A FALL ONTO AN OUTSTRETCHED ARM. GLENOID SPHERE AND BASEPLATE WERE REMOVED AND REPLACED WITH NEW COMPONENTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6084890 ↗
• InjuryAug 1, 2016Material Separation; Material Separation

  REVISION SURGERY DUE TO IMPLANT BREAKAGE - GLENOID. (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5836167 ↗
• InjuryJul 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY FOR INSTABILITY/DISLOCATION AT DAY 45 POST-OPERATIVE. BASEPLATE + GLENOID SPHERE + REVERSED INSERT WERE REMOVED. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5821316 ↗