AEQUALIS DWB243Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700386915529), received between Aug 10, 2016 and Jan 26, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion

  MAUDE report 24176447 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE SURGEON REMOVED AN AEQUALIS PRESS-FIT ANATOMIC HUMERAL PROSTHESIS AND AEQUALIS GLENOID ANATOMIC IMPLANT AT ST VINCENT¿S PRIVATE HOSPITAL EAST MELBOURNE. DUE TO SUSPECTED (NOT CONFIRMED) INFECTION. A CEMENT ZIMMER SPACER WAS IMPLANTED. AEQUALIS PRESS FIT STEM (UNKNOWN CATALOG NUMBER), MEDIUM POLY GLENOID, UNKNOWN CATALOG NUMBERS.

  Patient problems: Unspecified Infection

  MAUDE report 20072998 ↗
• InjuryOct 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY FOR LOOSENING/LYSIS 11 YEARS POST-OPERATIVE. PATIENT ID : (B)(6)."

  Patient problems: Inadequate Osseointegration

  MAUDE report 7984476 ↗
• InjurySep 5, 2018Adverse 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 IMPLANT BREAKAGE (GLENOID IMPLANT) WITH PAIN (GLENOID WEAR, GLENOID IMPLANT BREAKAGE, ROTATOR CUFF INSUFFICIENCY, GLENOID BONE LOSS WERE ALL LISTED AS REASONS FOR REVISION. PATIENT ID: (B)(6).

  Patient problems: Pain; Patient Problem/Medical Problem

  MAUDE report 7845531 ↗
• InjuryFeb 16, 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 AFTER 10 YEARS FOR GLENOID LOOSENING. CONVERSION TO RSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6335138 ↗
• InjuryDec 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AT 10 YEARS POST-OPERATIVE FOR ROTATOR CUFF INSUFFICIENCY. THE IMPLANTED STEM, HUMERAL HEAD AND GLENOID COMPONENT WERE REMOVED. CONVERSION INTO RSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6184867 ↗
• InjuryAug 10, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY DISLOCATION. THE IMPLANTED STEM AND HUMERAL HEAD WERE REMOVED FOR CONVERSION IN RSA WITH ANOTHER MANUFACTURER'S STEM AND INSERT, AND WITH A TORNIER GLENOID SPHERE. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5864394 ↗