AEQUALIS REVERSED II DWE735Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700386952678), received between Jul 8, 2024 and Nov 28, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (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 Problem2
- Osseointegration Problem1
Patient problems
- Bacterial Infection1
- Implant Pain1
- Inadequate Osseointegration1
- Sepsis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 28, 2024Osseointegration Problem; Osseointegration Problem
AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. LEFT SHOULDER PAIN. SUBJECT EXPERIENCED INCREASED PAIN IN SHOULDER. THE CT SHOWED EARLY LOOSENING OF THE CENTRAL SCREW ON THE BASEPLATE. 2 STAGE-REVISION SURGERY: (B)(6) 2022: SUBJECT UNDERWENT RESECTION ARTHROPLASTY WITH PLACEMENT OF ANTIBIOTIC SPACER (1ST STAGE REVISION). (B)(6) 2022: IMPLANTATION OF REVIVE DUE TO SUBJECT EXPERIENCED INCREASED PAIN IN SHOULDER. THE CT SHOWED EARLY LOOSENING OF THE CENTRAL SCREW ON THE BASEPLATE (2ND STAGE REVISION)".
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 20804947 ↗InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: "SUBJECT:(B)(6) REV1. INFECTION. PATIENT REQUIRED IRRIGATION AND DEBRIDEMENT ALONG WITH ANTIBIOTICS."
Patient problems: Bacterial Infection
MAUDE report 20349587 ↗InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT REQUIRED REVISION SURGERY AS THERE WAS TEARING OF THE GLENOID DUE TO SEPSIS.
Patient problems: Sepsis
MAUDE report 19697171 ↗
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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