AEQUALIS GLENOID DWB211Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03700386915420), received between Dec 6, 2016 and May 21, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  INDEX SURGERY 2011, OLD AEQUALIS CEMENTED ANATOMIC STEM AND AEQUALIS KEELED GLENOID. DONE FOR IMPLANT LOOSENING ON GLENOID SIDE. CEMENTED STEM WAS STILL WELL FIXED. SUSPECTED INFECTION.

  Patient problems: Inadequate Osseointegration; Medical device site infection

  MAUDE report 22064159 ↗
• InjuryApr 20, 2023Migration; Migration

  IT WAS REPORTED THAT PATIENT (B)(6) UNDERWENT A REVISION SURGERY OF THE GLENOID DUE TO LOOSENING/LYSIS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Osteolysis

  MAUDE report 16777562 ↗
• InjuryJan 12, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS, 15 YEARS AFTER PRIMARY SURGERY. PATIENT ID: (B)(6).

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 11153630 ↗
• InjuryMay 15, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT HAD A GLENOID COMPONENT LOOSENING 14 YEARS AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8611449 ↗
• 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. (B)(6)."

  Patient problems: Inadequate Osseointegration

  MAUDE report 7984484 ↗
• InjurySep 5, 2018Break; Break

  "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. (B)(6).

  Patient problems: Failure of Implant

  MAUDE report 7845527 ↗
• InjuryMay 29, 2018Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT HAD A GLENOID COMPONENT LOOSENING 13 YEARS POST-OPERATIVE. THE PATIENT IS LOOKING TO HAVE A REVISION, BUT DUE TO BONE HEALTH IS CURRENTLY ON TYMLOS TREATMENT. PATIENT ID: (B)(4).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7548930 ↗
• InjuryDec 6, 2017Naturally Worn; Naturally Worn

  "IT WAS REPORTED THAT A PATIENT HAD BEEN EXPERIENCING A GLENOID COMPONENT LOOSENING, PAIN AND LOSS OF RANGE OF MOTION, 11 YEARS POST-OPERATIVE. PATIENT ID: (B)(6)".

  Patient problems: Pain

  MAUDE report 7086200 ↗
• InjuryNov 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 FOR GLENOID LOOSENING 9 YEARS POST OPERATIVE. PATIENT: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7013157 ↗
• 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 6335137 ↗
• InjuryDec 6, 2016Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY AT 8.5 YEARS POST-OPERATIVE DUE TO GLENOID IMPLANT WEAR. CONVERSION TO RSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6147346 ↗