AEQUALIS™ FLEX REVIVE™ ARS655102Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832069415), received between May 26, 2021 and Apr 14, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Break; Fracture; Break; Fracture

  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 16742379 ↗
• MalfunctionJul 25, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO CONVERT A HEMI ARTHROPLASTY TO A REVERSE SHOULDER ARTHROPLASTY. THE PROXIMAL BODY WAS LOOSE UPON REVISION OF HEMI ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY. PROXIMAL BODY, ASSEMBLY SCREW, LOCKING CAP AND SPACER ALL HAD TO BE REMOVED. SHORT STEM HAD TO BE CEMENTED ON TOP OF DISTAL STEM WHICH COULD NOT BE REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 15100108 ↗
• InjuryMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER SURGERY. SOMETIME POST-OP THE LOCKING CAP/ASSEMBLY SCREW FAILED CAUSING THE PROSTHESIS TO DISASSEMBLE IN-SITU. THE PATIENT WILL NEED TO UNDERGO A REVISION PROCEDURE TO CORRECT THE PROBLEM. UPDATE: THE PATIENT HAD LOW ACTIVITY LEVEL. THE T20 SCREWDRIVER WAS USED FIRST FOLLOWED BY USING THE T20 DRIVER BIT AND TORQUE LIMITING HANDLE TO COMPLETE THE ASSEMBLY OF THE PROSTHESIS. INFO NOT AVAILABLE WHEN PATIENT WAS MADE AWARE OF FAILURE. NO REMARKABLE CIRCUMSTANCES WERE PRESENT WHEN USED. THE REVIVE HUMERAL WAS USED BECAUSE OF A FRACTURE TO THE PROXIMAL HUMERUS.

  Patient problems: Failure of Implant

  MAUDE report 11888668 ↗