AEQUALIS REVERSED II DWD183Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03700386935855), received between Oct 3, 2016 and Sep 8, 2025 — classified as 10 injuries, 2 malfunctions.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 22993434 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT WAS REVISED DUE TO AN INFECTION. ALL THE IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22668608 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1ST STAGE REVISION OF AEQUALIS REVERSED II HUMERUS/ GLENOID DUE TO LONG STANDING INFECTION, AQUIRED 18 MONTHS POST INDEX SURGERY. SURGEON SAID IT WAS NOT PRODUCT FAULT. CAUSE OF INFECTION NOT RELATED TO PRODUCT. SIMPLY NOTIFYING THAT THESE PROSTHESIS WERE EXPLANTED. NATURE OF INFECTION AND BUG UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22063982 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT 008-00042 SHOUT - TORNIER SHOULDER OUTCOMES STUDY PAIN IN THE SHOULDER DUE TO A FALL."

  Patient problems: Fall; Implant Pain

  MAUDE report 21045861 ↗
• InjuryAug 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Dislocation

  MAUDE report 17538189 ↗
• InjuryJul 10, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT MAY HAVE AN ALLERGIC REACTION WHICH CAUSED LOOSENING OF THE STEM. THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT WAS CONFIRMED TO HAVE A NICKEL ALLERGY. THE ONLY COMPONENT WITH NICKEL IS THE GLENOSPHERE.

  Patient problems: Metal Related Pathology; Osteolysis

  MAUDE report 17292990 ↗
• InjuryJun 28, 2023Adverse 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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2017 A PATIENT REQUIRED REVISION SURGERY DUE CONVERSION TOTAL TO HEMI - OTHER, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : "CONVERSION TO ARTHRODESIS¿.

  Patient problems: Insufficient Information

  MAUDE report 17217451 ↗
• MalfunctionSep 28, 2021Difficult to Insert; Difficult to Insert

  THE CUSTOMER REPORTED THAT THE GLENOSPHERE WOULD NOT ATTACH ONTO BASEPLATE. A DIFFERENT GLENOPSHERE WAS USED. THIS WAS A DIFFERENT SIZED IMPLANT AND THE SURGEON HAD TO USE A DIFFERENT HUMERAL COMPONENT TO MATCH. THE SAME BASE PLATE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544230 ↗
• MalfunctionNov 16, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE CENTRAL SCREW OF THE GLENOSPHERE COULD NOT BE SCREWED INTO THE THREAD OF THE BASEPLATE, AFTER MANY ATTEMPTS WITHIN HALF AN HOUR, ANOTHER GLENOSPHERE WAS USED.

  Patient problems: Failure of Implant

  MAUDE report 10842496 ↗
• InjurySep 4, 2020Detachment of Device or Device Component; Ejection Problem; Detachment of Device or Device Component; Ejection Problem

  AEQUALIS REVERSED PROSTHESIS IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020 DURING A CONSULTATION, WE OBSERVED THE DISASSEMBLY OF THE GLENOID SPHERE. REVISION SURGERY AND IMPLANTATION OF A NEW GLENOID SPHERE AND INSERT.

  Patient problems: Joint Disorder; Joint Laxity

  MAUDE report 10493694 ↗
• InjuryJan 16, 2017Disassembly; Disassembly

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO GLENOSPHERE DISSOCIATION AND INSTABILITY/DISLOCATION. TRAY AND POLY ALSO REMOVED. STEM AND BASEPLATE REMAINED FROM PREVIOUS SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 6253643 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY ON (B)(6) 2016 FOR GLENOSPHERE DISSOCIATION WITH BASEPLATE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5992982 ↗