AEQUALIS™ PerFORM DWE401Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700386937453), received between Mar 6, 2017 and Jun 26, 2018 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO PAIN AND BAD ROTATOR CUFF MUSCLES.

  Patient problems: Muscle Weakness/Atrophy; Pain; Patient Problem/Medical Problem

  MAUDE report 7637476 ↗
• InjuryMar 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FEELS SHOULDER IS GOING TO POP OUT OF PLACE. PATIENT STATED IT TENDS TO HAPPEN SEVERAL TIMES A DAY. PATIENT THINKS SHOULD MAY POP OUT THE BACK OF THE SOCKET. X-RAY SHOWS SOME BONE RESORPTION, POSSIBLE STRESS SHIELDING AROUND PROXIMAL ASPECT OF THE HUMERUS, LUCENCY AROUND CENTRAL POST. CT SCAN ORDERED TO EVALUATE POSSIBLE GLENOID LOOSENING. PATIENT ID : (B)(4).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7344615 ↗
• InjuryMar 6, 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 ROTATOR CUFF INSUFFICIENCY. CONVERSION TO REVERSE SHOULDER ARTHROPLASTY. THE STEM FORM PREVIOUS SURGERY REMAINED IMPLANTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6379875 ↗