AEQUALIS REVERSED FRACTURE DWD978Recalls & reported problems
Tornier · Retentive Insert · Class 2 · Implant
All models of AEQUALIS REVERSED FRACTURE (15)
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 03700386936401), received between Nov 21, 2022 and Feb 12, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation2
- Failure of Implant1
- Fall1
- Insufficient Information1
- Subluxation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE SECOND REVISION SURGERY THAT OCCURRED ON (B)(6) 2023 FROM RETENTIVE +12 (DWD978) & LATERALISED 29X42MM (DWD194) GLENOSPHERE THEN TO A SPACER (DWD920) AND +6MM INSERT (DWD976) AND ECCENTRIC GLENOSPHERE (DWD195). NO FURTHER INFORMATION WAS PROVIDED. LATER, IT WAS REPORTED DURING THIRD REVISION THAT, BACKGROUND ON THE PATIENT IS THAT HE SADLY HAS AN ALCOHOL PROBLEM HENCE THE MANY FALLS LEADING TO DISLOCATIONS, NOT COMPLIANT WITH REHAB.,WITH AN INCREASED RISK OF INFECTION.
Patient problems: Fall; Insufficient Information; Subluxation
MAUDE report 24322771 ↗InjuryAug 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION DURING WHICH THE HUMERAL ARTICULATING BEARING WAS REVISED.
Patient problems: Joint Dislocation
MAUDE report 17537977 ↗InjuryNov 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THERE A DISLOCATION. THE REVISION WAS COMPLETED WITH A POLY INSERT AND A SPACER.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 15834334 ↗
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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