AEQUALIS REVERSED DWE001Recalls & reported problems
Tornier · Class 2 · Implant
All models of AEQUALIS REVERSED (41)
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 03700386936562), received between Jan 3, 2017 and Mar 26, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Disassembly” (3 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 Problem3
- Disassembly3
- Mechanical Problem2
Patient problems
- Patient Problem/Medical Problem4
- Failure of Implant3
- Medical device site infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN INFECTION WAS FOUND IN THE KNEE AND SPINE IMPLANT, AND THE SHOULDER WAS ALSO SUSPECTED OF BEING INFECTED. THE REVISION SURGERY FOR REMOVING IMPLANTS WAS SCHEDULED ON (B)(6) 2025.
Patient problems: Medical device site infection
MAUDE report 21698910 ↗InjurySep 14, 2017Disassembly; Mechanical Problem; Disassembly; Mechanical Problem
REVISION SURGERY OF AN AEQUALIS REVERSE FOR IMPLANT FAILURE DUE TO A BROKEN IMPLANT. THE MALE THREADED POST BROKE AND HUMERAL IMPLANTS CAME APART. PATIENT WAS PULLING UP PANTS AND FELT FUNNY POP.
Patient problems: Failure of Implant; Patient Problem/Medical Problem
MAUDE report 6865129 ↗InjurySep 14, 2017Disassembly; Mechanical Problem; Disassembly; Mechanical Problem
REVISION SURGERY OF AN AEQUALIS REVERSE FOR IMPLANT FAILURE DUE TO A BROKEN IMPLANT. THE MALE THREADED POST BROKE AND HUMERAL IMPLANTS CAME APART. PATIENT WAS PULLING UP PANTS AND FELT FUNNY POP.
Patient problems: Failure of Implant; Patient Problem/Medical Problem
MAUDE report 6865117 ↗InjuryAug 18, 2017Disassembly; Adverse Event Without Identified Device or Use Problem; Disassembly; Adverse Event Without Identified Device or Use Problem
IN POSTOP VISIT PATIENTS XRAY SHOWED UNTHREADED HUMERAL METAPHYSIS FROM HUMERAL STEM. PATIENT HAD REVISION REVERSE TSA FOR FAILED IMPLANTS ON (B)(6) 2017. THE METAPHYSIS WAS FOUND TO HAVE PARTIALLY BECOME UNTHREADED FROM HUMERAL STEM AND BREAK OFF AT THE JUNCTION IN THE THREADED PART WHERE THE TEFLON PLUG GOES THROUGH.
Patient problems: Failure of Implant; Patient Problem/Medical Problem
MAUDE report 6803596 ↗InjuryJan 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2016: DURING SURGERY, GLENOID WAS FRACTURED. STEM AND HEAD WERE PLACED AND PHYSICIAN DECIDED TO WAIT ABOUT 6 MONTHS. ON (B)(6) 2016: WHEN THE PHYSICIAN REMOVED THE IMPLANTS TO REPLACE THEM ALL WITH COMPETITORS PRODUCTS, METALLOSIS WAS OBSERVED.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6218613 ↗
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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