AEQUALISRecalls & reported problems across all models

We found 15 models of AEQUALIS by Tornier in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2016 and Mar 10, 2026 — classified as 54 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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

Most reported AEQUALIS problems

AEQUALIS models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AEQUALIS DWB248

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  12 reports
• AEQUALIS DWB246

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  8 reports
• AEQUALIS DWB243

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  7 reports
• AEQUALIS DWB241

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  6 reports
• AEQUALIS DWB250

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  5 reports
• AEQUALIS DWB092

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  3 reports
• AEQUALIS DWB251

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS DWB091

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  2 reports
• AEQUALIS DWB237

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• AEQUALIS DWB239

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• AEQUALIS DWB252

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• AEQUALIS DWA012

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS DWB122

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS DWB253

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS DWB562

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  1 report

Recent AEQUALIS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 10, 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) 2026. 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 24556763 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT HAD PAIN. IT WAS ALSO REPORTED. ENOVIS TEAM WERE USED FOR THEIR STEM ONCE THE AEQUALIS AND PERFORM PEGGED WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 24278375 ↗
• InjuryJan 26, 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) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion

  MAUDE report 24176447 ↗
• InjuryDec 24, 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 WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR 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 IMPINGEMENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION (INCLUDES DAIR WITH MODULAR EXCHANGE AND MODULAR EXCHANGE FOR INDICATIONS OTHER THAN INFECTION).

  Patient problems: Joint Impingement

  MAUDE report 23886906 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE OLD PRESS FIT STEM AND CORTILOC GLENOID WERE REVISED DUE TO PAIN IN PATIENT. NO FURTHER PATIENT ADVERSE CONSEQUENCES REPORTED, REVISION WENT AS PLANNED.

  Patient problems: Implant Pain

  MAUDE report 23477854 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; 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: Medical device site infection

  MAUDE report 22063984 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE SURGEON REMOVED AN AEQUALIS PRESS-FIT ANATOMIC HUMERAL PROSTHESIS AND AEQUALIS GLENOID ANATOMIC IMPLANT AT ST VINCENT¿S PRIVATE HOSPITAL EAST MELBOURNE. DUE TO SUSPECTED (NOT CONFIRMED) INFECTION. A CEMENT ZIMMER SPACER WAS IMPLANTED. AEQUALIS PRESS FIT STEM (UNKNOWN CATALOG NUMBER), MEDIUM POLY GLENOID, UNKNOWN CATALOG NUMBERS.

  Patient problems: Unspecified Infection

  MAUDE report 20072998 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION OF HEMI TO REVERSE SHOULDER FOR INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 19924574 ↗
• InjuryMay 31, 2024Adverse 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 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) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19434632 ↗
• InjuryMay 20, 2024Adverse 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 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) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19354182 ↗
• 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 19001137 ↗
• InjuryJan 26, 2024Unstable; Unstable

  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) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 18592049 ↗
• 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 16782253 ↗
• 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 16782034 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 16782012 ↗

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
• Blueprint4 models · 0 reports · 1 recall