AEQUALIS REVERSED DWB950Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03700386916250), received between May 10, 2017 and May 21, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Missing Value Reason” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1ST STAGE REVISION OF AEQUALIS REVERSED II HUMERUS/ GLENOID DUE TO LONG STANDING INFECTION, ACQUIRED 18 MONTHS POST INDEX SURGERY. SURGEON SAID IT WAS NOT PRODUCT FAULT. CAUSE OF INFECTION NOT RELATED TO PRODUCT. SIMPLY NOTIFYING THAT THESE PROSTHESIS WERE EXPLANTED. NATURE OF INFECTION AND BUG UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 22063979 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 18987637 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALL THE IMPLANTS WERE REMOVED DUE TO INFECTION AND THE IMPLANT SITE WAS FILLED WITH A CEMENT CONTAINING ANTIBIOTICS. THE PATIENT IS RECEIVING CONSERVATIVE TREATMENT. NO X-RAY IMAGES WERE AVAILABLE. INSERTION SITE: TO BE PROVIDED. COMMENTS FROM DR. :THE INFECTION HAS NOTHING TO DO WITH THE DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 13606849 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS AN AEQUALIS REVERSE POST APPROVAL STUDY REPORT. ON (B)(4) 2015: DURING THE AEQUALIS REVERSE INITIAL SURGERY, THE HUMERUS FRACTURED SLIGHTLY WHEN THE IMPLANT WAS INSERTED. AT THE DISCRETION OF THE SURGEON, NO SPECIFIC TREATMENT WAS GIVEN.

  Patient problems: Bone Fracture(s)

  MAUDE report 12004706 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "ON THE SURGERY ON (B)(6) 2018, THE IMPLANT AT THE GLENOID SIDE WAS REMOVED AND THE HUMERAL IMPLANT WAS REPLACED TEMPORARILY TO THE HUMERAL HEAD. AT THAT TIME, THE INFECTION WAS RELATIVELY MILD, SO THE STEM IMPLANT WAS LEFT. BUT THIS TIME, THE INFECTION WAS SERIOUS, SO THE SURGEON DECIDED TO PERFORM REVISION SURGERY ON (B)(6) AND REMOVE THE STEM IMPLANT. (THE IMPLANTED DATE WAS 2014)"

  Patient problems: Unspecified Infection

  MAUDE report 8792852 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Missing Value Reason; Adverse Event Without Identified Device or Use Problem; Missing Value Reason

  SINCE THE PATIENT HAD INFECTION, ALL IMPLANTS WERE REMOVED AND THE INSERTION SITE WAS FILLED WITH A CEMENT CONTAINING ANTIBIOTICS. THE PATIENT RECEIVED CONSERVATIVE TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 6556556 ↗