AEQUALIS GLENOIDRecalls & reported problems across all models
Tornier · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls
- 0
We found 11 models of AEQUALIS GLENOID by Tornier in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Sep 27, 2016 and May 21, 2025 — classified as 45 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AEQUALIS GLENOID problems
Device problems
- Adverse Event Without Identified Device or Use Problem22
- Loosening of Implant Not Related to Bone-Ingrowth8
- Migration4
- Naturally Worn4
- Osseointegration Problem4
- Device Dislodged or Dislocated3
- Loss of Osseointegration2
- Break1
Patient problems
- Patient Problem/Medical Problem27
- Inadequate Osseointegration5
- Osteolysis5
- Failure of Implant4
- Pain4
- Implant Pain2
- Fall1
- Medical device site infection1
AEQUALIS GLENOID models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AEQUALIS GLENOID DWB211PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED11 reports
- AEQUALIS GLENOID DWB213PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED8 reports
- AEQUALIS GLENOID DWB212PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- AEQUALIS GLENOID DWB217PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- AEQUALIS GLENOID DWB002PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS GLENOID DWB003PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS GLENOID DWB216PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS GLENOID DWB218PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS GLENOID DWB210PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS GLENOID DWB001PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS GLENOID DWB215PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
Recent AEQUALIS GLENOID adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 21, 2025Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
INDEX SURGERY 2011, OLD AEQUALIS CEMENTED ANATOMIC STEM AND AEQUALIS KEELED GLENOID. DONE FOR IMPLANT LOOSENING ON GLENOID SIDE. CEMENTED STEM WAS STILL WELL FIXED. SUSPECTED INFECTION.
Patient problems: Inadequate Osseointegration; Medical device site infection
MAUDE report 22064159 ↗InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 21771797 ↗InjuryMar 28, 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 DUE TO PAIN.
Patient problems: Implant Pain
MAUDE report 18999680 ↗InjuryMay 9, 2023Naturally Worn; Osseointegration Problem; Migration; Naturally Worn; Osseointegration Problem; Migration
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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE "ASEPTIC LOOSENING GLENOID/GLENOID IMPLANT WEAR/LYSIS - HUMERUS/LYSIS - GLENOID", WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : "SINGLE STAGE REVISION¿.
Patient problems: Osteolysis
MAUDE report 16898439 ↗InjuryMay 9, 2023Osseointegration Problem; Osseointegration Problem
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. 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) 2019 A PATIENT REQUIRED REVISION SURGERY DUE "OTHER/ASEPTIC LOOSENING GLENOID/STIFFNES", WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : "SINGLE STAGE REVISION.¿
Patient problems: Osteolysis
MAUDE report 16898351 ↗InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
IT WAS REPORTED THAT THERE WAS A REVISION SURGERY WAS UNDERWENT DUE TO A ROTATOR CUFF INSUFFICIENCY.
Patient problems: Inadequate Osseointegration; Muscle/Tendon Damage
MAUDE report 16782256 ↗InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS A REVISION SURGERY DUE TO PAIN.
Patient problems: Pain
MAUDE report 16782035 ↗InjuryApr 20, 2023Migration; Migration
IT WAS REPORTED THAT PATIENT (B)(6) UNDERWENT A REVISION SURGERY OF THE GLENOID DUE TO LOOSENING/LYSIS. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Osteolysis
MAUDE report 16777562 ↗InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem
IT WAS REPORTED THERE WAS A REVISION OF AN OLD TOTAL SHOULDER. DURING REVISION THEY HAD A HUMERAL SHAFT FRACTURE. ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED BY 2 HOURS.
Patient problems: Fall; Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions
MAUDE report 16102138 ↗InjuryJul 18, 2022Migration; Migration
PATIENT PRESENTED TO SURGEON SEVERAL MONTHS AGO WITH INCREASING PAIN IN PROSTHETIC SHOULDER JOINT. PATIENT UNDERWENT REMOVAL OF ANATOMIC SHOULDER REPLACEMENT PROSTHESIS DUE TO ROTATOR CUFF TENDON DEGENERATION AND LOOSENING OF GLENOID COMPONENT. GLENOID COMPONENT BECAME LOOSE DUE TO OSTEOLYSIS BEHIND THE COMPONENT, ACCORDING TO SURGEON. A REVERSE SHOULDER REPLACEMENT PROSTHESIS WAS SUBSEQUENTLY IMPLANTED.
Patient problems: Implant Pain; Osteolysis
MAUDE report 15048475 ↗InjuryAug 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT HAD POST-OPERATIVE COMPLICATIONS. THE PATIENT COMPLAINED OF PAIN AND X-RAYS REVEALED A LOOSE GLENOID COMPONENT.
Patient problems: Failure of Implant; Pain
MAUDE report 12316337 ↗InjuryJan 12, 2021Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING/LYSIS, 15 YEARS AFTER PRIMARY SURGERY. PATIENT ID: (B)(6).
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 11153630 ↗InjuryApr 3, 2020Material Erosion; Material Erosion
DR. (B)(6) EXPLANTED THE GLENOID, THE HUMERAL HEAD AND HUMERAL STEM. HE COMMENTED ON THE SIGNIFICANT WEAR OF THE GLENOID.
Patient problems: Patient Problem/Medical Problem
MAUDE report 9920221 ↗InjuryApr 2, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
"IT WAS REPORTED THAT A PATIENT HAD A GLENOID LOOSENING 13 YEARS AFTER PRIMARY SURGERY, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020, PATIENT ID: (B)(6)".
Patient problems: Patient Problem/Medical Problem
MAUDE report 9915127 ↗InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration
"IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ANTEROSUPERIOR ESCAPE, 9 YEARS AFTER PREVIOUS SURGERY. PATIENT ID: (B)(6)".
Patient problems: Muscle Weakness/Atrophy
MAUDE report 9792835 ↗
Other Tornier products
- Tornier Flex Shoulder System91 models · 791 reports
- Blueprint Mixed Reality8 models · 0 reports · 9 recalls
- AEQUALIS REVERSED II46 models · 405 reports
- AEQUALIS REVERSED41 models · 258 reports
- FLEX SHOULDER SYSTEM35 models · 194 reports
- Tornier Perform Anatomic Glenoid25 models · 81 reports
- Aequalis Ascend Flex30 models · 79 reports
- AEQUALIS15 models · 56 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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