AEQUALIS DWB246Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03700386915536), received between Jan 17, 2017 and Feb 6, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Migration” (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 16, 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 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT HAD PAIN. IT WAS ALSO REPORTED. ENOVIS TEAM WERE USED FOR THEIR STEM ONCE THE AEQUALIS AND PERFORM PEGGED WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 24278375 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF HEMI TO REVERSE SHOULDER FOR INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 19924574 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO PAIN.

  Patient problems: Implant Pain

  MAUDE report 19001137 ↗
• InjuryDec 21, 2020Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  THE COMPONENTS HAVE BEEN IMPLANTED IN (B)(6) AND EXPLANTED IN (B)(6) BECAUSE OF ASEPTIC LOOSENING OF THE STEM AND DISASSEMBLY OF THE HUMERAL HEAD FROM ITS STEM. BOTH THE COMPONENTS HAVE BEEN EXPLANTED BUT THE PARTS WILL BE RETAINED BY THE HOSPITAL WHO DOESN'T EXPECT A RESPONSE FROM THE COMPANY.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 11045294 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ANTEROSUPERIOR ESCAPE, 9 YEARS AFTER PREVIOUS SURGERY. PATIENT ID: (B)(6)"

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 9792834 ↗
• 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 7159710 ↗
• 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 6256022 ↗
• 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 7 YEARS FOR LOOSENING/LYSIS. CONVERSION TO RSA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6255706 ↗