AEQUALIS GLENOID DWB213Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03700386915444), received between Jan 12, 2017 and Feb 20, 2019 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT COMPLAINS OF PAIN WITH ACTIVITY AND THE XRAYS REVEAL A LOOSE OF GLENOID COMPONENT. SUBJECT ID: (B)(6).

  Patient problems: Pain; Patient Problem/Medical Problem

  MAUDE report 8353333 ↗
• InjuryJan 2, 2019Loosening 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 LOOSENING/LYSIS 14 YEARS POST-OPERATIVE. SUBJECT ID: (B)(6)."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8207830 ↗
• InjuryMar 2, 2018Naturally Worn; Naturally Worn

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO IMPLANT BREAKAGE (GLENOID INSERT) 11 YEARS POST-OPERATIVE. PATIENT ID: (B)(6)."

  Patient problems: Failure of Implant

  MAUDE report 7308955 ↗
• InjuryDec 27, 2017Material Separation; Material Separation

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR GLENOID IMPLANT BREAKAGE 11 YEARS POST-OPERATIVE. PATIENT ID : (B)(6)".

  Patient problems: Failure of Implant

  MAUDE report 7147358 ↗
• InjuryNov 22, 2017Disassembly; Disassembly

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO GLENOID LOOSENING/LYSIS, 7 MONTHS POST-OP. (TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2004 - DIAGNOSTIC ARTHROSCOPY OF THE GLENOHUMERAL JOINT ON (B)(6) 2004) PATIENT ID: (B)(6)."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7052189 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD BEEN EXPERIENCING A LOOSENING OF THE GLENOID COMPONENT. SUBJECT UNDERWENT REMOVAL OF IMPLANTS AND REVISION SURGERY. PATIENT ID : (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6692282 ↗
• InjuryJun 9, 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 12 YEARS FOR LOOSENING/LYSIS. CONVERSION TO RSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6629422 ↗
• InjuryJan 12, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AFTER 10 YEARS DUE TO INSTABILITY/DISLOCATION. CONVERSION TO RSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6245645 ↗