AEQUALIS REVERSED II DWD990Recalls & reported problems
Tornier · Class 2 · Implant
All models of AEQUALIS REVERSED II (46)
Data updated Oct 18, 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 03700386932755), received between Jun 16, 2017 and Apr 28, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Unstable” (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 Problem3
- Unstable1
Patient problems
- Pain2
- Joint Laxity1
- Medical device site infection1
- Patient Problem/Medical Problem1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2025Unstable; Unstable
PATIENT UNDERWENT PRIMARY SURGERY. PRESENTED TO ORIGINAL SURGEON COMPLAINING OF PAIN AND SHOULDER WAS ALSO UNSTABLE. DECISION TO REVISE COMPONENTS. REVISION SURGERY SCHEDULED FOR REVISING POLYETHELENE COMPONENT REMOVED ONLY. REPLACED WITH NEW COMPONENTS. QUERIED FOR INFECTION.
Patient problems: Joint Laxity; Medical device site infection; Pain
MAUDE report 21920359 ↗InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH AN INTERNAL STUDY THAT THE PATIENT ON (B)(6) 2022 EXPERIENCED POST-OPERATIVE COMPLICATION AFTER REVISION SURGERY. THERE WAS PERSISTENT MEDIAL SCAPULAR AND DEEP SHOULDER PAIN. EMG FINDINGS PREOP INDICATED CHRONIC C5 RADICULOPATHY AND DENERVATION OF INFRASPINATUS MUSCLE. THE PATIENT IS TAKING OVER THE COUNTER PAIN MEDICATION.
Patient problems: Pain
MAUDE report 16305058 ↗InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD POSITIVE INTRAOPERATIVE CULTURES THAT WERE MANAGED WITH IV ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 15332062 ↗InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY/DISLOCATION.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6646305 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page