AEQUALIS REVERSED FRACTURERecalls & reported problems across all models
Tornier · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls
- 0
We found 15 models of AEQUALIS REVERSED FRACTURE by Tornier in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2017 and Sep 18, 2026 — classified as 39 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 REVERSED FRACTURE problems
Device problems
- Adverse Event Without Identified Device or Use Problem22
- Device Dislodged or Dislocated12
- Unstable4
- Device Slipped2
- Biocompatibility1
- Defective Component1
- Device Damaged Prior to Receipt by User1
- Inaccurate Information1
Patient problems
- Unspecified Infection16
- Joint Dislocation8
- Subluxation6
- Joint Laxity4
- Patient Problem/Medical Problem4
- Failure of Implant2
- Fall2
- Insufficient Information2
AEQUALIS REVERSED FRACTURE models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AEQUALIS REVERSED FRACTURE DWD860shoulder prosthesis, reverse configuration6 reports
- AEQUALIS REVERSED FRACTURE DWD966PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- AEQUALIS REVERSED FRACTURE DWD967PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED5 reports
- AEQUALIS REVERSED FRACTURE DWD968PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED4 reports
- AEQUALIS REVERSED FRACTURE DWB010PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS REVERSED FRACTURE DWD972PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS REVERSED FRACTURE DWD978PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- AEQUALIS REVERSED FRACTURE DWD920PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS REVERSED FRACTURE DWD922PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS REVERSED FRACTURE DWD901PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS REVERSED FRACTURE DWD970PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- AEQUALIS REVERSED FRACTURE DWD932PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 report
- AEQUALIS REVERSED FRACTURE DWD976PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS REVERSED FRACTURE DWD861PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- AEQUALIS REVERSED FRACTURE DWD862shoulder prosthesis, reverse configuration1 report
Recent AEQUALIS REVERSED FRACTURE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Device Dislodged or Dislocated
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 Aug 2026.During the review of the report, it was identified that on (b)(6)2025 a patient required revision surgery due to INFECTION, DISLOCATION/SUBLUXATION, which was not previously reported to the manufacturer.
Patient problems: Subluxation; Unspecified Infection
MAUDE report 50820670 ↗InjuryJun 8, 2026Device Dislodged or Dislocated
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) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Subluxation
MAUDE report 25426045 ↗InjuryApr 15, 2026Adverse 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 BETWEEN SEPTEMBER 2025 - FEBRUARY 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 24889096 ↗InjuryMar 10, 2026Adverse 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) 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 24556873 ↗InjuryMar 3, 2026Unstable
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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Joint Laxity
MAUDE report 24494110 ↗InjuryFeb 23, 2026Adverse 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) 2024. 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 24413944 ↗InjuryFeb 18, 2026Unstable
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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Joint Laxity
MAUDE report 24380767 ↗InjuryFeb 16, 2026Adverse 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 AUG. 2024. 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 24342415 ↗InjuryFeb 13, 2026Device Dislodged or Dislocated
THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN MARCH 2023 - SEPTEMBER 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO CUFF INSUFFICIENCY/OTHER/DISLOCATION/SUBLUXATION/TRAUMATIC DISLOCATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Subluxation
MAUDE report 24331296 ↗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 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE REVISION OF LINER, SPACER AND GLENOSPHERE WAS DONE DUE TO INFECTION THAT SPREAD FROM ANOTHER JOINT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 24080104 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, THE REVISION OF LINER, SPACER AND GLENOSPHERE WAS DONE DUE TO INFECTION THAT SPREAD FROM ANOTHER JOINT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 24080100 ↗InjuryDec 10, 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) 2025, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Unspecified Infection
MAUDE report 23768659 ↗InjuryDec 1, 2025Unstable; Unstable
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 IN 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Joint Laxity
MAUDE report 23687366 ↗InjuryNov 28, 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) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO CUFF INSUFFICIENCY, LYSIS - HUMERUS & LYSIS - GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.
Patient problems: Osteolysis
MAUDE report 23671486 ↗
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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