AEQUALIS GLENOID DWB212Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03700386915437), received between Dec 6, 2016 and Apr 3, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2020Material Erosion; Material Erosion

  DR. (B)(6) EXPLANTED THE GLENOID, THE HUMERAL HEAD AND HUMERAL STEM. HE COMMENTED ON THE SIGNIFICANT WEAR OF THE GLENOID.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9920221 ↗
• InjuryApr 2, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "IT WAS REPORTED THAT A PATIENT HAD A GLENOID LOOSENING 13 YEARS AFTER PRIMARY SURGERY, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020, PATIENT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9915127 ↗
• InjuryApr 12, 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 ASEPTIC GLENOID LOOSENING 11 YEARS AFTER PRIMARY SURGERY. SUBJECT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8508785 ↗
• InjurySep 18, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  "GROSS LOOSENING OF GLENOID WITH MIGRATION INTO AXILLARY RECESS. LOOSENING OF HUMERAL HEAD COMPONENT WITH NOTCHING OF THE MEDIAL PROXIMAL HUMERUS JUST BELOW THE IMPLANT. PATIENT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7884673 ↗
• InjuryNov 21, 2017Adverse 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 13 YEARS POST-OP. (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7048083 ↗
• InjuryDec 6, 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 11 YEARS POST-OPERATIVE DUE TO LOOSENING/LYSIS. THE IMPLANTED STEM, HUMERAL HEAD AND GLENOID COMPONENT WERE REMOVED. CONVERSION INTO (B)(4).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6148015 ↗