AEQUALIS REVERSED DWB936Recalls & reported problems
Tornier · Class 2 · Implant
All models of AEQUALIS REVERSED (41)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700386916151), received between Apr 27, 2017 and Sep 17, 2023 — classified as 5 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 16, 2026.
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
- Loss of Osseointegration1
Patient problems
- Bacterial Infection2
- Metal Related Pathology2
- Patient Problem/Medical Problem2
- Implant Pain1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 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 17762354 ↗InjuryMay 17, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN SHOULDER SYNOVECTOMY/DEBRIDEMENT PROCEDURE DUE TO HAVING A SEPTIC RIGHT SHOULDER INFECTION POSSIBLY CAUSED BY METALLOSIS DUE TO THE IMPLANT LOOSENING.
Patient problems: Metal Related Pathology; Unspecified Infection
MAUDE report 14415246 ↗InjuryApr 22, 2022Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT ATTENDED A REVISION SURGERY FOR A REVERSE II IMPLANT, IMPLANTED IN 2014. THE PATIENT REPORTED WITH PAIN, LOOSENING AND INFECTION. IT'S POSSIBLE THAT THE INFECTION WAS CAUSED BY METALOSIS DUE TO IMPLANT LOOSENING.
Patient problems: Bacterial Infection; Implant Pain; Metal Related Pathology
MAUDE report 14186448 ↗InjuryJan 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY ONE MONTH POST-OPERATIVE (TOTAL SHOULDER REPLACEMENT) DUE TO ANTERIOR DISLOCATION OF REVERSED SHOULDER. EXPLANTATION OF THE HUMERAL INSERT ONLY. PATIENT ID : (B)(6).
Patient problems: Patient Problem/Medical Problem
MAUDE report 7193175 ↗InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS AT 4 YEARS POST-OPERATIVE. POLY WAS LOOSE (KNOWN), STEM LOOSE (IDENTIFIED INTRA-OP). PREVIOUS GLENOID BASEPLATE LEFT IN PLACE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6525817 ↗
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 16, 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