AEQUALIS REVERSED II DWE825Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700386952722), received between Mar 21, 2018 and Feb 25, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINS OF EVERYDAY SHOULDER PAIN. HE HAS SIGNIFICANT PAIN, LACK OF MOTION, AND WEAKNESS. PATIENT WAS PUT IN A NURSING HOME AFTER SURGERY WHERE LITTLE FOCUS WAS ON SHOULDER RANGE OF MOTION AND STRENGTHENING. X-RAYS SHOW NO SIGNS OF FRACTURES OR LOOSENING OF IMPLANTS. PATIENT WANTS TO HAVE HIS KNEE TAKEN CARE OF FIRST BEFORE SHE CONSIDERS SURGICAL INTERVENTION ON THEIR SHOULDER. PATIENT ID : (B)(6).

  Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy; Pain

  MAUDE report 13607038 ↗
• InjuryMar 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR INSTABILITY-DISLOCATION. TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2002. REVISION SURGERIES ON (B)(6) 2015, (B)(6) 2016 AND (B)(6) 2017 (AEQUALIS PRESS FIT STEM DWB273 + AEQUALIS TITANIUM HUMERAL HEAD DWA239). PATIENT ID : (B)(6)."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7357551 ↗