AEQUALIS GLENOID DWB217Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386915475), received between Jan 17, 2017 and Jul 18, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2022Migration; Migration

  PATIENT PRESENTED TO SURGEON SEVERAL MONTHS AGO WITH INCREASING PAIN IN PROSTHETIC SHOULDER JOINT. PATIENT UNDERWENT REMOVAL OF ANATOMIC SHOULDER REPLACEMENT PROSTHESIS DUE TO ROTATOR CUFF TENDON DEGENERATION AND LOOSENING OF GLENOID COMPONENT. GLENOID COMPONENT BECAME LOOSE DUE TO OSTEOLYSIS BEHIND THE COMPONENT, ACCORDING TO SURGEON. A REVERSE SHOULDER REPLACEMENT PROSTHESIS WAS SUBSEQUENTLY IMPLANTED.

  Patient problems: Implant Pain; Osteolysis

  MAUDE report 15048475 ↗
• InjuryJan 21, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE GLENOID COMPONENT, 9 YEARS AFTER INITIAL SURGERY. PATIENT ID : (B)(6)."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9610137 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING-LYSIS 9 YEARS POST-OP. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7159713 ↗
• InjuryJan 17, 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 11 YEARS FOR LOOSENING/LYSIS. CONVERSION TO RSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6256029 ↗