Aequalis Reversed II MWB175Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700386969133), received between Dec 29, 2017 and Dec 29, 2017 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVERSE SHOULDER REPLACEMENT. A TRIAL PROSTHESIS WAS ASSEMBLED, IMPLANTED AND REMOVED. WHEN THE PERMANENT PROSTHESIS WAS SUBSEQUENTLY BEING ASSEMBLED, THE TRIAL METAPHYSEAL COMPONENT WAS INADVERTENTLY ATTACHED TO THE IMPLANT HOLDER AND IMPLANTED IN THE PATIENT. THE FLAWED IMPLANT WAS SHORTLY THEREAFTER THROUGH REVIEW OF A FLUOROSCOPY FILM. IN ORDER TO COMPLETE THE PROCEDURE, IT WAS NECESSARY TO REMOVE THE FLAWED PROSTHESIS WHICH WAS DIFFERENT DIFFICULT SINCE THE CEMENT HAD CURRED. IN THE END THE SURGEON ELECTED TO PERFORM AN OSTEOTOMY OF THE PROXIMAL HUMERUS. THE MANEUVERING OF THE SOFT BONE RESULTED IN A FRACTURE OF THE DISTAL HUMERUS. THE SURGEON ULTIMATELY WAS ABLE TO INSERT ANOTHER PROSTHESIS AND THE PATIENT WAS DISCHARGED 3 DAYS LATER. PROBLEM IDENTIFIED: TRIAL MODULAR COMPONENTS WERE NOT EASILY DISTINGUISHABLE FROM THE PERMANENT MODULAR COMPONENTS WHICH WAS A DIRECT CAUSE OF THE USER ERROR.

  Patient problems: No Information

  MAUDE report 7153962 ↗