AEQUALIS REVERSED DWD002Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700386916618), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Disassembly” (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.
Most reported problems
Device problems
- Disassembly1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Fall1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2018Disassembly; Loosening of Implant Not Related to Bone-Ingrowth; Disassembly; Loosening of Implant Not Related to Bone-Ingrowth
"2014 AEQUALIS REVERSED OPERATION. ON (B)(6) 2018: THE PATIENT FELL WHICH MAY HAVE CAUSED LOOSENING OF GLENOID SPHERE AND BASEPLATE. AS A LITTLE SWELLING AND PUS WERE SEEN IN THE INSERTION SITE, THE SURGEON DECIDED TO REMOVE THE IMPLANTS. (B)(6) 2018: AS THE INFECTION WAS ONLY THE SURFACE OF THE SKIN, ONLY THE GLENOID SPHERE, INSERT AND BASEPLATE WERE REMOVED AND A HEAD WAS IMPLANTED. COMMENT FROM SURGEON: IF INFECTION WAS VERY SERIOUS, I WAS GOING TO REMOVE ALL THE IMPLANTS BUT IT WAS NOT SO SERIOUS, SO I JUST LEFT THE STEM AND IMPLANTED A HEAD. THIS PATIENT SEEMED TO HAVE SOME KIND OF INFECTION AFTER THE SURGERY 4 YEARS AGO BUT IT DID NOT BECOME SERIOUS. SO, THIS COMPONENT LOOSENING CAN BE THE CAUSE OF THIS INCIDENT."
Patient problems: Fall; Unspecified Infection
MAUDE report 7285264 ↗
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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