AEQUALIS™ FLEX REVIVE™ ARS342001Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846832067824), received between Jul 26, 2022 and Feb 4, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
- Osseointegration Problem1
Patient problems
- Discomfort1
- Failure of Implant1
- Inadequate Osseointegration1
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2025Osseointegration Problem; Osseointegration Problem
AS REPORTED: "REVIVE HUMERAL STEM APPEARS TO BE SEPARATING. THE LOCKING CAP AND THE ASSEMBLY SCREWS SEEM TO BE BACKING OUT CAUSING THE PROXIMAL BODY, THE SPACER AND THE DISTAL STEM TO BE MIGRATING AWAY FROM EACH OTHER."
Patient problems: Inadequate Osseointegration
MAUDE report 21307603 ↗InjuryOct 22, 2024Adverse 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 DUE TO DISCOMFORT.
Patient problems: Discomfort
MAUDE report 20507944 ↗InjuryApr 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
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 16739785 ↗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 15104402 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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