AEQUALIS REVERSED FRACTURE DWB010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700386931871), received between May 28, 2020 and Sep 4, 2024 — 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.

• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "THE DETAILS ARE UNKNOWN, THE PRIMARY SURGERY FOR ARTIFICIAL SHOULDER JOINT REPLACEMENT WAS PERFORMED AT ANOTHER HOSPITAL ABOUT 6 YEARS AGO. ABOUT 2 YEARS AGO, THE PERIPROSTHETIC SHOULDER JOINT FRACTURE AROUND THE ARTIFICIAL SHOULDER JOINT WAS OCCURRED AND PERFORMED THE PLATING SURGERY. AFTER PLATING SURGERY, THE SURGERY FOR REMOVING THE PLATE AND SCREWS WAS PERFORMED DUE TO INFECTION. ON (B)(6) 2024, THE SURGERY FOR REMOVING ARTIFICIAL SHOULDER JOINT WAS PERFORMED DUE TO THE INFECTION AROUND THE STEM".

  Patient problems: Unspecified Infection

  MAUDE report 20133400 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION WAS FOUND IN A PATIENT AFTER ARTIFICIAL SHOULDER JOINT SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 16202887 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE INITIAL SURGERY OF AEQUALIS REVERSED FRACTURE WAS PERFORMED. (B)(6) 2020, A DISLOCATION OCCURRED AT THE AFFECTED PART. OPERATION WAS PERFORMED ON (B)(6) 2020. THE METAPHYSICAL PLUG AND INSERT HAVE BEEN REMOVED AND REPLACED WITH A NEW SPACER ((B)(4)) AND INSERT ((B)(4)). SINCE THE PATIENT WAS LYING DOWN AND WATCHING HIS TV WITH HIS ELBOWS ON, THE SURGEON THINKS THAT HE WAS STRUCTURALLY VULNERABLE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 10095463 ↗