AEQUALIS REVERSED DWD032Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386916663), received between Jan 11, 2019 and Sep 17, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Most reported problems
Device problems
- Material Fragmentation2
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Bacterial Infection1
- Failure of Implant1
- Foreign Body In Patient1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 17762351 ↗MalfunctionFeb 25, 2022Material Fragmentation; Material Fragmentation
WHILE LOCKING THE SCREW, WITHOUT MORE POWER, THE SCREW HEAD BROKE OFF. THE REST OF THE SCREW WAS LEFT AND STILL GAVE COMPRESSION TO THE BASEPLATE, BUT NO LOCKING ANY MORE. THE OTHER LOCKING SCREW WAS WITHOUT PROBLEMS LOCKING.
Patient problems: Failure of Implant
MAUDE report 13606712 ↗MalfunctionAug 16, 2021Material Fragmentation; Material Fragmentation
PATIENT UNDERWENT A ROUTINE REVERSE TOTAL SHOULDER. POSTOP IMAGES SHOWED A SLIVER OF TWISTED METAL.
Patient problems: Foreign Body In Patient
MAUDE report 12328587 ↗MalfunctionJan 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS 3 YEARS POST-OPERATIVE, WITH ONE BROKEN MULTIDIRECTIONAL SCREW. SUBJECT ID: (B)(4).
Patient problems: Patient Problem/Medical Problem
MAUDE report 8239667 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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