AEQUALIS™ FLEX REVIVE™ ARS655200Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832069576), received between May 19, 2021 and Jul 15, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 16, 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.

• InjuryJul 15, 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 22512412 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 15104633 ↗
• 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 11888692 ↗
• InjuryMay 19, 2021Difficult to Insert; Difficult to Insert

  UPON ASSEMBLING THE REVIVE STEM CONSTRUCT, THE ASSEMBLY SCREW, PROXIMAL BODY, DISTAL STEM AND SPACERS WERE CONNECTED USING THE BLACK HANDLE TORQUE LIMITED ASSEMBLY SCREWDRIVER. THE LOCKING CAP WAS PLACED INSIDE THE PROXIMAL BODY AND LOCKED WITH THE TORQUE LIMITED SCREWDRIVER. THE STEM WAS ATTACHED TO THE BROACH HANDLE AND IMPLANTED (UNCEMENTED) INTO THE PATIENT. WHEN THE TRAY WAS PLACED ONTO THE PROXIMAL BODY, THE MORSE TAPER DID NOT ENGAGE. THE LOCKING CAP WAS UNSCREWED THEN RE-TIGHTENED ENCASE THIS WAS INITIALLY CROSS THREADED. THE TRAY WOULD STILL NOT ENGAGE TO THE PROXIMAL BODY. THE LOCKING CAP WAS AGAIN REMOVED AND SUBSEQUENTLY DROPPED. THE SURGEON ASKED IF THE LOCKING CAP WAS A REQUIREMENT WHICH I RESPONDED ¿YES, IT PREVENTS THE ASSEMBLY SCREW FROM BACKING OUT¿. THE SPARE LOCKING CAP WAS OPENED AND SCREWED IN PLACE. THE TRAY STILL DID NOT ENGAGE. AT THIS POINT THE SURGEON SAID TOO MUCH TIME HAD BEEN WASTED AND WAS SATISFIED THAT THE ASSEMBLY SCREW WAS FULLY ENGAGED, FULLY TIGHTENED AND WOULD PROCEED WITHOUT THE LOCKING CAP. THE SURGERY WAS COMPLETED BY IMPLANTING THE TRAY AND POLY INSERT. SURGERY WAS COMPLETED BY NOT IMPLANTING A LOCKING CAP, THE STEM WAS ALREADY IMPLANTED, N

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852066 ↗
• InjuryMay 19, 2021Difficult to Insert; Difficult to Insert

  UPON ASSEMBLING THE REVIVE STEM CONSTRUCT, THE ASSEMBLY SCREW, PROXIMAL BODY, DISTAL STEM AND SPACERS WERE CONNECTED USING THE BLACK HANDLE TORQUE LIMITED ASSEMBLY SCREWDRIVER. THE LOCKING CAP WAS PLACED INSIDE THE PROXIMAL BODY AND LOCKED WITH THE TORQUE LIMITED SCREWDRIVER. THE STEM WAS ATTACHED TO THE BROACH HANDLE AND IMPLANTED (UNCEMENTED) INTO THE PATIENT. WHEN THE TRAY WAS PLACED ONTO THE PROXIMAL BODY, THE MORSE TAPER DID NOT ENGAGE. THE LOCKING CAP WAS UNSCREWED THEN RE-TIGHTENED ENCASE THIS WAS INITIALLY CROSS THREADED. THE TRAY WOULD STILL NOT ENGAGE TO THE PROXIMAL BODY. THE LOCKING CAP WAS AGAIN REMOVED AND SUBSEQUENTLY DROPPED. THE SURGEON ASKED IF THE LOCKING CAP WAS A REQUIREMENT WHICH I RESPONDED ¿YES, IT PREVENTS THE ASSEMBLY SCREW FROM BACKING OUT¿. THE SPARE LOCKING CAP WAS OPENED AND SCREWED IN PLACE. THE TRAY STILL DID NOT ENGAGE. AT THIS POINT THE SURGEON SAID TOO MUCH TIME HAD BEEN WASTED AND WAS SATISFIED THAT THE ASSEMBLY SCREW WAS FULLY ENGAGED, FULLY TIGHTENED AND WOULD PROCEED WITHOUT THE LOCKING CAP. THE SURGERY WAS COMPLETED BY IMPLANTING THE TRAY AND POLY INSERT. SURGERY WAS COMPLETED BY NOT IMPLANTING A LOCKING CAP, THE STEM WAS ALREADY IMPLANTED, N

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11851940 ↗