AEQUALIS™ FLEX REVIVE™ ARS742301Recalls & reported problems
Tornier, Inc. · Class 2
All models of AEQUALIS FLEX REVIVE (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832068678), received between Sep 6, 2022 and Apr 10, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
- Fracture2
- Corroded1
- Material Deformation1
- Naturally Worn1
Patient problems
- Insufficient Information1
- Limb Fracture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2024Break; Fracture; Break; Fracture
THIS EVENT IS BEING FILED TO NOTE THE DISTAL STEM TRIAL BEING STUCK AND THE NEED FOR AN OSTEOTOMY TO REMOVE IT. - A 90 MINUTE SURGICAL DELAY WAS REPORTED. ADDITIONALLY, INFORMATION IS AVAILABLE WHICH INDICATES THE BREAKAGE.
Patient problems: Insufficient Information
MAUDE report 19082152 ↗InjuryDec 1, 2023Break; Corroded; Fracture; Detachment of Device or Device Component; Material Deformation; Naturally Worn; Break; Corroded; 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 18251038 ↗MalfunctionSep 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE DISENGAGEMENT OF THE DISTAL BODY OF THE TRIAL STEM FROM THE PROXIMAL BODY, WITH THE RETROVERSION ROD STILL ATTACHED TO THE INTRODUCER HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY FRACTURING THE HUMERUS PROXIMALLY, REMOVING THE REMAINING PART OF THE TRIAL STEM INSIDE AND RE-TRAILING WITH A NEW CONSTRUCT, FOLLOWED BY THE FINAL IMPLANT. THIS RESULTED IN A 45 MIN DELAY.
Patient problems: Limb Fracture
MAUDE report 15362492 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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