AEQUALIS™ FLEX REVIVE™ ARS741701Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
All models of AEQUALIS FLEX REVIVE (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832069286), received between Jun 5, 2025 and Feb 16, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated2
- Biocompatibility1
- Loss of Osseointegration1
Patient problems
- Bacterial Infection1
- Extraskeletal ossification1
- Insufficient Information1
- Metal Related Pathology1
- Osteolysis1
- Pain1
- Subluxation1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2026Device Dislodged or Dislocated
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 COMPONENT DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Subluxation
MAUDE report 24342754 ↗InjuryJan 28, 2026Loss of Osseointegration
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 JULY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO ASEPTIC LOOSENING HUMERUS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis
MAUDE report 24198192 ↗InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem
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) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO HETEROTOPIC OSSIFICATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Extraskeletal ossification
MAUDE report 24198183 ↗InjuryJul 15, 2025Biocompatibility; Device Dislodged or Dislocated; 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: Insufficient Information; Metal Related Pathology; Pain
MAUDE report 22512410 ↗InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE REVERSE SHOULDER ARTHROPLASTY WAS DONE FOR INFECTION. THE SURGEON MENTIONED ENTEROCOCCI WAS DETECTED. THE IMPLANTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED. NO PRODUCT FAULT WAS REPORTED.
Patient problems: Bacterial Infection
MAUDE report 22154009 ↗
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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