AEQUALIS REVERSED FRACTURE DWD968Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386936371), received between Apr 27, 2017 and Sep 18, 2026 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Device 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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 Aug 2026.During the review of the report, it was identified that on (b)(6)2025 a patient required revision surgery due to INFECTION, DISLOCATION/SUBLUXATION, which was not previously reported to the manufacturer.

  Patient problems: Subluxation; Unspecified Infection

  MAUDE report 50820670 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 22993431 ↗
• InjuryAug 21, 2017Device 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 WILL UNDERGO A REVISION SURGERY TO FIX INSTABILITY ISSUES. PATIENT ID : (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6806692 ↗
• InjuryApr 27, 2017Adverse 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 DUE TO LOOSENING/LYSIS AT 4 YEARS POST-OPERATIVE. POLY WAS LOOSE (KNOWN), STEM LOOSE (IDENTIFIED INTRA-OP). PREVIOUS GLENOID BASEPLATE LEFT IN PLACE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6525807 ↗