AEQUALIS REVERSED II DWH907Recalls & 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 03700386955136), received between Feb 20, 2020 and Mar 6, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Unstable1
Patient problems
- Unspecified Infection2
- Implant Pain1
- Joint Dislocation1
- Joint Disorder1
- Joint Laxity1
- Muscle/Tendon Damage1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 27, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated
IT WAS REPORTED THAT THERE WAS A NEED FOR A REVISION OF REVERSE SHOULDER DUE TO DISLOCATION FOLLOWING PRIMARY REVERSE. THE SURGEON DECIDED TO REVISE THE IMPLANTS IN PLACE TO GIVE GREATER LATERALIZATION. HE ALSO USED A THICKER CONSTRAINED LINER. THE PATIENT HAD A TORN SUBSCAPULARIS AND THEREFORE THE JOINT WAS UNSTABLE WHICH REQUIRED THIS REVISION. IMPLANTS WERE REVISED TO GIVE GREATER STABILITY AND MORE LATERALIZATION.
Patient problems: Joint Dislocation; Joint Laxity; Muscle/Tendon Damage
MAUDE report 20321944 ↗InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT MAY HAVE AN ALLERGY TO THE IMPLANT. THE PATIENT IS ALSO EXPERIENCING PAIN. IT WAS LATER FOUND THAT THE PATIENT HAD AN INFECTION AND WOULD NEED A REVISION SURGERY.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 18636298 ↗InjuryFeb 20, 2020Loosening 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 GLENOID LOOSENING 4 YEARS AFTER PRIMARY SURGERY. PATIENT ID: (B)(6)".
Patient problems: Joint Disorder
MAUDE report 9731943 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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