AEQUALIS™ FLEX REVIVE™ ARS741702Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832069293), received between Dec 10, 2020 and Feb 24, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 INSTABILITY WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24428915 ↗
• 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 16739788 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAIN ("WORSENING PAIN") IN HER RIGHT SHOULDER. POST-OPERATIVE COMPLICATION 5 MONTHS AFTER PREVIOUS SURGERY. ACTION TAKEN: MEDICATION ; INJECTION- 1ML KENALOG, 2ML LIDOCAINE, 7ML ROPIVICAINE. PATIENT IS ALSO SEEING A NEUROLOGIST AND WILL FOLLOW UP WITH US AFTER 3 MONTHS.

  Patient problems: Implant Pain

  MAUDE report 13578817 ↗
• InjuryFeb 17, 2022Positioning Failure; Positioning Failure

  WE HAD TO REVISE BECAUSE THE MORSE TAPER FROM IMPLANT DWF520 AND ARS741702 DID NOT ENGAGE DURING FIRST REVISION, SO SURGEON WANTED TO MAKE SURE THE MORSE TAPER MECHANICS WERE SOUND. PERIPROSTHETIC FRACTURE WAS TREATED. THE EVENT WAS RESOLVED WITH STEM UPSIZED TO A 13 AND A THICKER TRAY WAS USED AS WELL.

  Patient problems: Bone Fracture(s)

  MAUDE report 13552286 ↗
• InjuryDec 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON THE SHOULDER. ALLEGEDLY THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10988162 ↗