AEQUALIS REVERSED FRACTURE DWD967Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700386936364), received between Nov 17, 2022 and Dec 10, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 ON (B)(6) 2025, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23768659 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE REVISION SURGERY WAS PERFORMED WHEREIN THE EXCHANGE OF POLY LINER ON AEQUALIS REVERSE FRACTURE STEM WAS DONE. LATERALISED 9MM 42 LINER REMOVED. REPLACED WITH A 9MM SPACER AND 6MM RETENTIVE 42 LINER. PATIENT HAS A 42 LATERALISED SPHERE INSITU. IT WAS REPORTED THAT, HE HAD RECURRENT DISLOCATIONS DUE TO HIS BEHAVIOUR- ALCOHOLIC AND NON COMPLIANT.

  Patient problems: Subluxation

  MAUDE report 23649267 ↗
• InjuryMar 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 21552287 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 (B)(6) 2012 ¿ (B)(6) 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 17538186 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SHOULDER REPLACEMENT. THE PATIENT REPORTED OOZING OF THE WOUND POST-PROCEDURE. AN EXPLORATION SURGERY AND CULTURE REVEALED THE PRESENCE OF AN INFECTION. THE FIRST STAGE OF THE REVISION WAS COMPLETED WITH A WASH OUT.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 15821668 ↗