AEQUALIS REVERSED FRACTURE DWD966Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700386936357), received between Jan 5, 2017 and Apr 15, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 BETWEEN SEPTEMBER 2025 - FEBRUARY 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24889096 ↗
• InjurySep 30, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, THE POLY INSERT WAS REVISED DUE TO DISLOCATION/ INSTABILITY. PATIENT FACTORS CONTRIBUTING TO DISLOCATION WERE LIKELY AXILLARY NERVE PALSY AND FAILURE OF TUBEROSITY REPAIR ON RIGHT HAND SIDE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23185326 ↗
• InjuryMar 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY/DISLOCATION 1 YEAR POST-OPERATIVE. SUBJECT ID: (B)(6)".

  Patient problems: Joint Dislocation; Patient Problem/Medical Problem

  MAUDE report 8390707 ↗
• InjuryFeb 1, 2019Device Slipped; Adverse Event Without Identified Device or Use Problem; Device Slipped; Adverse Event Without Identified Device or Use Problem

  SEVERE PERIPROSTHETIC INFECTION IDENTIFIED AT THE TIME OF ARTHROTOMY WHICH WAS AN UNEXPECTED FINDING. THE SHOULDER WAS THEN DISLOCATED AND THE MODULAR COMPONENTS FROM THE HUMERAL STEM EXPLANTED. AT THE INTERFACES OF THE MODULAR COMPONENTS, EXTENSIVE PURULENT MATERIAL WAS IDENTIFIED. ANY INFECTED OR NECROTIC APPEARING TISSUE WAS REMOVED. WITH THE MODULAR COMPONENTS OF THE HUMERAL STEM REMOVED, THE MORE POSTERIOR ASPECTS OF THE SHOULDER JOINT WERE DEBRIDED. ONCE ALL MODULAR COMPONENTS WERE REMOVED AND SHARP EXCISIONAL DEBRIDEMENT COMPLETED, A SERIES OF IRRIGATION MANEUVERS WAS PERFORMED. 3 L OF STERILE SALINE WAS IRRIGATED THROUGH THE JOINT USING PULSATILE LAVAGE. THIS WAS FOLLOWED BY A 2-MINUTE DILUTE HYDROGEN PEROXIDE SOLUTION LAVAGE AND FURTHER PULSATILE IRRIGATION OF 3 L STERILE SALINE. THIS WAS THEN FOLLOWED BY A 3-MINUTE DILUTE BETADINE LAVAGE AND AN ADDITIONAL 3 L OF STERILE SALINE THROUGH PULSATILE IRRIGATION. AT THE CONCLUSION OF THESE IRRIGATION MANEUVERS, A SURGICALLY CLEAN SHOULDER JOINT WAS ACHIEVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8296302 ↗
• InjuryJan 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY / DISLOCATION. POLY INSERT AND GLENOSPHERE WERE SWAPPED OUT, ALL OTHER COMPONENTS REMAINED THE SAME.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6225518 ↗