AEQUALIS REVERSED DWD026Recalls & reported problems
Tornier · Class 2 · Implant
All models of AEQUALIS REVERSED (41)
Data updated Oct 18, 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 03700386916649), received between May 24, 2023 and Mar 11, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Fracture1
- Osseointegration Problem1
Patient problems
- Bacterial Infection1
- Foreign Body In Patient1
- Inadequate Osseointegration1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2024Break; Fracture; Break; Fracture
DURING THE TIGHTENING OF A DWD026 LOCKING SCREW FOR THE REVERSE II GLENOID SYSTEM, THE SCREW'S HEAD BROKE CLEANLY. DESPITE BEING SUFFICIENTLY TIGHTENED WITH NO ADDITIONAL EFFORT REQUIRED AND THE INCIDENT WAS REPORTED. THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.
Patient problems: Foreign Body In Patient
MAUDE report 18876170 ↗InjurySep 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT IN THE TORNIER SHOULDER OUTCOMES STUDY DEVELOPED AN INFECTION, SPECIFICALLY P. ACNES. THIS INFECTION WAS TREATED WITH A 6-WEEK COURSE OF INTRAVENOUS (IV) ANTIBIOTICS. FOLLOWING THE IV ANTIBIOTICS, THE PATIENT WAS STARTED ON ORAL SUPPRESSION THERAPY WITH SEQUELAE.
Patient problems: Bacterial Infection
MAUDE report 17762355 ↗InjuryMay 24, 2023Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT THE REV II BASEPLATE, SCREWS, AND GLENOSPHERE WERE REMOVED BECAUSE OF NOTCHING AND LOOSENING.
Patient problems: Inadequate Osseointegration
MAUDE report 16997511 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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