AEQUALIS™ FLEX REVIVE™ ARS741801Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00846832069590), received between Apr 13, 2023 and Feb 16, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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

• InjuryFeb 16, 2026Device Dislodged or Dislocated

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 24342746 ↗
• InjuryJan 28, 2026Loss of Osseointegration

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING HUMERUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 24198189 ↗
• InjuryJan 28, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON 28-NOV-2023 A PATIENT REQUIRED REVISION SURGERY DUE TO HETEROTOPIC OSSIFICATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Extraskeletal ossification

  MAUDE report 24198178 ↗
• InjuryJul 29, 2025Loss of Osseointegration; Biocompatibility; Device Dislodged or Dislocated; Loss of Osseointegration; Biocompatibility; Device Dislodged or Dislocated

  A REVISION SURGERY WAS REQUIRED FOLLOWING THE DISENGAGEMENT OF THE TRAY FROM THE REVIVE STEM IN AN ACTIVE, INDEPENDENTLY MOBILE PATIENT WHO PRESENTED WITH ACUTE SHOULDER PAIN. INTRAOPERATIVE FINDINGS REVEALED A LOOSE STEM, FAILURE AT THE MORSE TAPER INTERFACE, PSEUDOMEMBRANE FORMATION AROUND THE TRAY, AND SIGNIFICANT METALLOSIS. THE STEM, TRAY, AND LINER WERE REVISED USING A LARGER STEM SIZE, WHILE THE GLENOSPHERE AND SCREWS REMAINED INTACT DUE TO STABLE FIXATION. POSTOPERATIVELY, THE PATIENT UNDERWENT STANDARD REHABILITATION, INCLUDING SLING IMMOBILIZATION FOR 3 TO 4 WEEKS FOLLOWED BY GENTLE MOBILIZATION UNDER PHYSIOTHERAPY SUPERVISION. X-RAY IMAGES ARE NOT INCLUDED DUE TO PATIENT CONFIDENTIALITY.

  Patient problems: Inadequate Osseointegration; Metal Related Pathology; Pain

  MAUDE report 22649378 ↗
• InjuryMay 20, 2025Adverse 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 (B)(6) 2013 ¿ (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023, A PATIENT REQUIRED REVISION SURGERY DUE TO HETEROTOPIC OSSIFICATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Extraskeletal ossification

  MAUDE report 22056221 ↗
• InjuryApr 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN ALLEGED THAT DURING THE INITIAL PROCEDURE THE PHYSICIAN LEFT TOO MUCH STEM EXPOSED WITHOUT PLACING SOME SORT OF BONE STRUT ON THE INITIAL SURGERY. WITHOUT BONE TO SHARE THE LOAD WITH, THE FORCES ON THE EXPOSED HUMERAL STEM WERE TOO GREAT AND CAUSED THE ASSEMBLY SCREW TO BREAK AND THE PROXIMAL BODY TO ROTATE. THE PATIENT UNDERWENT A REVISION SURGERY BECAUSE THE ASSEMBLY SCREW SHEARED OFF, CAUSING THE PROXIMAL BODY TO ROTATE 180° AND THE PATIENT TO DISLOCATE.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 16739786 ↗