AEQUALIS™ FLEX REVIVE™ ARS742501Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00846832068814), received between Dec 1, 2023 and Apr 16, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Fracture; Material Protrusion/Extrusion

  BOTTOM HALF OF TRIAL HAS EXPANDED AND CANNOT BE USED ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896489 ↗
• MalfunctionJul 25, 2025Device Difficult to Program or Calibrate; Material Deformation; Device Difficult to Program or Calibrate; Material Deformation

  IT WAS REPORTED THAT A 9MM PROXIMAL BODY TRIAL NO LONGER TIGHTLY SECURES TO THE TRIAL STEMS OR TRIAL SPACERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613492 ↗
• MalfunctionApr 21, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT WHILE IMPACTING THE TRIAL ASSEMBLY INTO THE HUMERUS, THE PROXIMAL BODY DETACHED FROM THE STEM DUE TO BROKEN RETAINING TABS. THE STEM TRIAL REMAINED IN THE HUMERAL CANAL AND WAS REMOVED USING NEEDLE NOSE PLIERS. ALL DEBRIS WAS CONFIRMED REMOVED VIA X-RAY. THE CASE WAS DELAYED APPROXIMATELY 40 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877653 ↗
• MalfunctionDec 27, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "ONE OF THE 9X20 SPACERS WOULD NOT LOCK ONTO STEM. WE USED THE SECOND ONE IN THE SET SO DID NOT INTERRUPT THE CASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21030803 ↗
• MalfunctionOct 14, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROXIMAL BODY TRIAL WAS BENT AT THE BOTTOM DURING A CASE. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441038 ↗
• MalfunctionOct 8, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A TRAINING LAB SESSION AT THE ST. LOUIS HUB, THE TAB ON THE BOTTOM OF A SIZE 9 REVIVE PROXIMAL BODY BENT DURING ASSEMBLY. WHEN AN ATTEMPT WAS MADE TO STRAIGHTEN THE TAB, IT BROKE OFF COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397362 ↗
• InjuryDec 1, 2023Break; Fracture; Detachment of Device or Device Component; Material Deformation; Naturally Worn; Break; Fracture; Detachment of Device or Device Component; Material Deformation; Naturally Worn

  DURING A RECENT SURGERY FOR A TOTAL REVERSE FRACTURE CASE, A PORTION OF THE 9X20 TRIAL SPACER FROM THE TORNIER FLEX REVIVE HUMERAL INSTRUMENTS TRAY FRACTURED AND BECAME STUCK INSIDE THE HUMERAL CANAL. THIS INCIDENT CAUSED A SIGNIFICANT DELAY IN THE SURGERY. THE SURGICAL TEAM HAD TO REMOVE A SECTION OF THE HUMERUS TO ACCESS AND REMOVE THE TRAPPED TRIAL STEM, WHICH WAS LATER REATTACHED USING CERCLAGE. THE INCIDENT RESULTED IN A 3-HOUR SURGICAL DELAY, BUT ALL DEBRIS WAS SUCCESSFULLY REMOVED USING A BUR INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18251081 ↗