AEQUALIS REVERSED IIRecalls & reported problems across all models

We found 46 models of AEQUALIS REVERSED II by Tornier in the FDA's device registry (GUDID). Together they are named in 405 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2016 and Sep 21, 2026 — classified as 347 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (87 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 REVERSED II problems

AEQUALIS REVERSED II models

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

• AEQUALIS REVERSED II DWD180

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  108 reports
• AEQUALIS REVERSED II DWD190

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  40 reports
• AEQUALIS REVERSED II DWD193

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  30 reports
• AEQUALIS REVERSED II DWD182

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  24 reports
• AEQUALIS REVERSED II DWD181

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  21 reports
• AEQUALIS REVERSED II DWD170

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  15 reports
• Aequalis Reversed II DWD167

  BIT, DRILL
  14 reports
• AEQUALIS REVERSED II DWD183

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  12 reports
• AEQUALIS REVERSED II DWD194

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  12 reports
• AEQUALIS REVERSED II DWD195

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  11 reports
• AEQUALIS REVERSED II DWE730

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  10 reports
• AEQUALIS REVERSED II DWD171

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  9 reports
• AEQUALIS REVERSED II DWH904

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  9 reports
• AEQUALIS REVERSED II DWD191

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  8 reports
• AEQUALIS REVERSED II DWE830

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  8 reports
• AEQUALIS REVERSED II DWD988

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  7 reports
• AEQUALIS REVERSED II DWD989

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  7 reports
• AEQUALIS REVERSED II DWD192

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  7 reports
• AEQUALIS REVERSED II DWE835

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  5 reports
• Aequalis Reversed II MWD148

  EXTRACTOR
  5 reports
• AEQUALIS REVERSED II DWD990

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  4 reports
• AEQUALIS REVERSED II DWH905

  shoulder prosthesis, reverse configuration
  4 reports
• AEQUALIS REVERSED II DWH907

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  4 reports
• Aequalis Reversed II MWB107

  INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
  4 reports
• AEQUALIS REVERSED II DWD980

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS REVERSED II DWE735

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS REVERSED II DWE825

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• AEQUALIS REVERSED II DWD982

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED II DWD984

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED II DWD986

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED II DWD184

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED II DWD185

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED II DWE725

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED II DWE840

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED II DWE860

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED II DWE880

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED II DWE891

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED II DWH901

  shoulder prosthesis, reverse configuration
  1 report
• AEQUALIS REVERSED II DWH906

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• Aequalis Reversed II MWB138

  IMPACTOR
  1 report
• Aequalis Reversed II MWB175

  Orthopedic manual surgical instrument
  1 report
• Aequalis Reversed II MWB197

  IMPACTOR
  1 report
• Aequalis Reversed II MWB250

  Orthopedic manual surgical instrument
  1 report
• Aequalis Reversed II MWD150

  INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
  1 report
• Aequalis Reversed II MWD156

  INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
  1 report
• Aequalis Reversed II MWF702

  INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
  1 report

Recent AEQUALIS REVERSED II adverse event reports

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

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  A revision surgery was performed as a result of a suspected infection after the patient fell.

  Patient problems: Fall; Post Operative Wound Infection

  MAUDE report 50841161 ↗
• 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 August 2026.During the review of the report, it was identified that on (b)(6) 2025 a patient required revision surgery due to DISLOCATION/SUBLUXATION, which was not previously reported to the manufacturer.

  Patient problems: Subluxation

  MAUDE report 50815721 ↗
• InjurySep 18, 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 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 50815718 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  As reported: "Patient has re-presented to surgeon, following revision shoulder arthroplasty in (b)(6) 2026. Significant swelling and redness over wound, pain on movement. Wound re-opened, and surgeon concluded that the prosthetic joint was now infected. Decided to remove all prosthesis, as stage 1 of a 2-stage revision. Glenoid component was found to be very loose, easily removed as 1 x construct (revised at previous revision). Humeral component (not revised at previous revision) was found to be extremely well fixed. Humeral poly insert removed - significant wear noted (only been insitu since (b)(6) '26 revision). Proximal humeral vertical osteotomy was required to loosen and to break the bone / implant on growth. Stem eventually removed; osteotomy cabled back together with Nice Loops. Multiple tissue specimens collected; debridement; copious lavage attended; no antibiotic spacer implanted - gleno-humeral joint left dis-articulated.Plan - antibiotic regime until clinical markers indicate no infection, then the 2nd stage revision will be undertaken, using a "Custom Glenoid", to be manufactured by a competitor company."

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50790675 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  A revision was performed due to infection.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50054842 ↗
• MalfunctionJun 19, 2026Fracture

  DURING THE STANDARD INTRAOPERATIVE PROCEDURE, IT WAS DISCOVERED THAT THE TIP OF THE DRILL BIT WAS MISSING. SUSPECTING REMAINING THE BROKEN TIP IN THE PATIENT'S BODY, THE BASE PLATE, WHICH WAS ALREADY IMPLANTED IN THE PATIENT, WAS REMOVED FOR INSPECTION. AFTER THE SURGERY, THE DISTRIBUTOR CHECKED THE PHOTO, WHICH WAS TAKEN BETWEEN CLEANING COMPLETION AND STARTING STERILIZATION BEFORE SURGERY, AND FOUND THAT THE TIP OF THE DRILL BIT WAS ALREADY GONE AT THAT TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566194 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF OF A LEFT PROXIMAL HUMERAL HEAD FRACTURE FOLLOWING A FALL. THE PROCEDURE WAS REVISED TO A REVERSE SHOULDER ARTHROPLASTY DUE TO RADIOGRAPHIC EVIDENCE OF AVASCULAR NECROSIS OF THE HUMERAL HEAD. SHORTLY AFTER THE REVISION, THE PATIENT DEVELOPED A WOUND INFECTION WITH A CHRONIC DRAINING SINUS IN THE LEFT AXILLA. THE PATIENT REMAINED ON ORAL ANTIBIOTICS FOR APPROXIMATELY THREE YEARS. IN RECENT MONTHS, THE PATIENT REPORTED INCREASED PAIN AND DISCOMFORT IN THE LEFT SHOULDER. SINUS SWABS AND ASPIRATION CULTURES WERE POSITIVE FOR SERRATIA MARCESCENS AND STAPHYLOCOCCUS EPIDERMIDIS.

  Patient problems: Discomfort; Fluid Discharge; Pain; Post Operative Wound Infection

  MAUDE report 25526244 ↗
• 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) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 25426222 ↗
• InjuryApr 14, 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) 2026 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24873783 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THIS PATIENT HAD MULTIPLE REVISIONS. REVISION OF ALL STRYKER IMPLANTS WAS DONE DUE TO INFECTION, EVERYTHING WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 24710442 ↗
• 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 24494103 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT SADLY HAD AN ALCOHOL PROBLEM HENCE THE MANY FALLS LEADING TO DISLOCATIONS, NOT COMPLIANT WITH REHAB AND MORE LIKELY TO INFECT. THIS IS THE FOURTH REVISION OF THE SPACER, LINER AND GLENOSPHERE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Fall; Subluxation

  MAUDE report 24458228 ↗
• 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 (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24342837 ↗
• InjuryFeb 16, 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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 24342758 ↗
• InjuryFeb 16, 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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 24342743 ↗

Other Tornier products

• Tornier Flex Shoulder System91 models · 791 reports
• Blueprint Mixed Reality8 models · 0 reports · 9 recalls
• 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
• Blueprint4 models · 0 reports · 1 recall