AEQUALIS REVERSEDRecalls & reported problems across all models

We found 41 models of AEQUALIS REVERSED by Tornier in the FDA's device registry (GUDID). Together they are named in 258 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2016 and Sep 21, 2026 — classified as 238 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (28 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 problems

AEQUALIS REVERSED models

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

• AEQUALIS REVERSED DWB993

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  29 reports
• AEQUALIS REVERSED DWD132

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  26 reports
• AEQUALIS REVERSED DWB960

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  24 reports
• AEQUALIS REVERSED DWD126

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  19 reports
• AEQUALIS REVERSED DWD138

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  16 reports
• AEQUALIS REVERSED DWB945

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  15 reports
• AEQUALIS REVERSED DWD067

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  12 reports
• AEQUALIS REVERSED DWB940

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  11 reports
• AEQUALIS REVERSED DWB996

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  9 reports
• AEQUALIS REVERSED DWD120

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  9 reports
• AEQUALIS REVERSED DWD144

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  7 reports
• AEQUALIS REVERSED DWB950

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  6 reports
• AEQUALIS REVERSED DWB994

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  6 reports
• AEQUALIS REVERSED DWB936

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  5 reports
• AEQUALIS REVERSED DWB995

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  5 reports
• AEQUALIS REVERSED DWD003

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  5 reports
• AEQUALIS REVERSED DWD054

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  5 reports
• AEQUALIS REVERSED DWE001

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  5 reports
• AEQUALIS REVERSED DWD032

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  4 reports
• AEQUALIS REVERSED DWB931

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS REVERSED DWB935

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS REVERSED DWB961

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS REVERSED DWB991

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS REVERSED DWD020

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS REVERSED DWD026

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS REVERSED DWD041

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  3 reports
• AEQUALIS REVERSED DWB946

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• AEQUALIS REVERSED DWD038

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• AEQUALIS REVERSED DWD044

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  2 reports
• AEQUALIS REVERSED DWE045

  PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
  2 reports
• AEQUALIS REVERSED DWB932

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED DWB942

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED DWB951

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED DWB992

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED DWB997

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED DWB998

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED DWD002

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED DWD023

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED DWD029

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED DWD070

  PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
  1 report
• AEQUALIS REVERSED DWE050

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

Recent AEQUALIS REVERSED 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 50841157 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Fall; Post Operative Wound Infection

  MAUDE report 50826182 ↗
• 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 (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 50819879 ↗
• InjuryAug 19, 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 50321624 ↗
• InjuryAug 3, 2026Osseointegration Problem

  It was reported that, originally revision surgery cancelled due to unknown reasons. It was rebooked for (b)(6)2026. Surgeon had planned to revise glenoid due to glenoid loosening during a recent fall. During case, surgeon identified that arthroplasty joint had been infected in his opinion. All humeral and glenoid components were removed without difficulty. Multiple tissue samples were taken. Debridement and copious lavage was performed. Antibiotic cement spacer was implanted for a two stage revision. Dr (b)(6) stated that there were no clinical markers indicative of joint infection. Second stage revision planned for 2-3 months. No further x-ray & CT available No pathology report available No other pt details available. Second stage procedure using competitor product.

  Patient problems: Fall; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50122219 ↗
• InjuryAug 3, 2026Osseointegration Problem

  It was reported that, originally revision surgery cancelled due to unknown reasons. It was rebooked for (b)(6) 2026. Surgeon had planned to revise glenoid due to glenoid loosening during a recent fall. During case, surgeon identified that arthroplasty joint had been infected in his opinion. All humeral and glenoid components were removed without difficulty. Multiple tissue samples were taken. Debridement and copious lavage was performed. Antibiotic cement spacer was implanted for a two stage revision. Dr (b)(6) stated that there were no clinical markers indicative of joint infection. Second stage revision planned for 2-3 months. No further x-ray & CT available No pathology report available. No other pt details available. Second stage procedure using competitor product.

  Patient problems: Fall; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 50121687 ↗
• InjuryMay 29, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a right primary reverse shoulder arthroplasty. At approximately two-year follow-up, the patient presented with shoulder pain and reduced range of motion. The surgeon noted reported non-compliance with postoperative rehabilitation and a history of potential trauma while climbing in and out of a truck.During revision surgery, the glenoid component was found to be loose and dissociated from the glenoid bone and was easily removed. The humeral component remained well fixed and was retained. The polyethylene insert exhibited eccentric wear, and grey synovial tissue was observed and excised. Copious lavage was performed.New glenoid components were implanted with the addition of synthetic bone graft. A new humeral polyethylene insert was placed. The shoulder was reduced and found to be stable through range of motion.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 25330998 ↗
• 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 MAY. 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 24342836 ↗
• InjuryFeb 12, 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 (B)(6) 2023 - (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO COMPONENT DISSOCIATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 24323362 ↗
• InjuryJan 7, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PROCEDURE WAS TO REVISE TO A REVERSE HOWEVER INTRAOP GLENOID FRACTURE OCCURRED AND SO A NEW COBALT CHROME HEAD WAS PUT ON THE EXISTING STEM AND NO GLENOID COMPONENT. THE REVISION SURGERY IS CAPTURED IN THE ORIGINAL PI 4147954. THIS PI WAS RAISED TO CAPTURE THE INTRAOP FRACTURE THAT OCCURRED DURING THE PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23991438 ↗
• InjuryJan 7, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PROCEDURE WAS TO REVISE TO A REVERSE HOWEVER INTRAOP GLENOID FRACTURE OCCURRED AND SO A NEW COBALT CHROME HEAD WAS PUT ON THE EXISTING STEM AND NO GLENOID COMPONENT. THE REVISION SURGERY IS CAPTURED IN THE ORIGINAL PI 4147954. THIS PI WAS RAISED TO CAPTURE THE INTRAOP FRACTURE THAT OCCURRED DURING THE PROCEDURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23991432 ↗
• InjuryJan 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, THE PATIENT HAD A REVISION FOR A BIO-RSA GLENOID PATIENT WHICH HAD APPEARED TO HAVE A RE-ABSORBED. THE SURGEON REMOVED THE GLENOSPHERE AND BASEPLATE WITH EASE FROM THE GLENOID SOCKET AND PACKED IT FULL WITH FEMORAL HEAD ALLOGRAFT. THE TRAY AND POLY WERE REMOVED FROM THE FLEX STEM AND SURGEON PLACED A 50X16 COCR FLEX HUMERAL HEAD ONTO THE STEM TO TURN IT TO A HEMI. IT WAS REPORTED IN A FINAL REPORT FROM SURGEON, THE RIGHT SHOULDER PROSTHESIS WAS DISLOCATED WITH THE HUMERAL END LYING INFERIOR TO THE GLENOID PROSTHETIC MARGIN. EXTENSIVE OSTEOLYSIS SURROUNDING THE GLENOID COMPONENT.

  Patient problems: Subluxation

  MAUDE report 23976916 ↗
• InjuryJan 6, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, THE PATIENT HAD A REVISION FOR A BIO-RSA GLENOID PATIENT WHICH HAD APPEARED TO HAVE A RE-ABSORBED. THE SURGEON REMOVED THE GLENOSPHERE AND BASEPLATE WITH EASE FROM THE GLENOID SOCKET AND PACKED IT FULL WITH FEMORAL HEAD ALLOGRAFT. THE TRAY AND POLY WERE REMOVED FROM THE FLEX STEM AND SURGEON PLACED A 50X16 COCR FLEX HUMERAL HEAD ONTO THE STEM TO TURN IT TO A HEMI. IT WAS REPORTED IN A FINAL REPORT FROM SURGEON, THE RIGHT SHOULDER PROSTHESIS WAS DISLOCATED WITH THE HUMERAL END LYING INFERIOR TO THE GLENOID PROSTHETIC MARGIN. EXTENSIVE OSTEOLYSIS SURROUNDING THE GLENOID COMPONENT.

  Patient problems: Subluxation

  MAUDE report 23976695 ↗
• InjuryJan 5, 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) 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 23958148 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, REVISION SURGERY WAS PERFORMED. 2 STAGE PROCEDURE AS LIKELY TO BE INFECTED. PRIMARY SURGERY WAS PERFORMED ON 3/6/22 WITH ASCEND FLEX AND REVERSE II IMPLANTS. ALL IMPLANTS WERE REMOVED AND PICTURED. A CEMENT SPACER WAS PLACED IN. IT WAS FURTHER REPORTED, THE PATIENT HAD PAIN AND SURGEON ORDERED X-RAYS (THESE WERE ATTACHED IN MY SUBMISSION) AND SURGEON NOTICED BONE REABSORPTION. DID NOT EXPECT INFECTION AS NO PATHOLOGY TESTS INDICATED IT. HOWEVER IN REVISION SURGEON THERE WAS STRONG EVIDENCE OF INFECTION WITH PUS AND INFECTED TISSUE.

  Patient problems: Implant Pain; Osteolysis; Unspecified Infection

  MAUDE report 23871281 ↗

Other Tornier products

• Tornier Flex Shoulder System91 models · 791 reports
• Blueprint Mixed Reality8 models · 0 reports · 9 recalls
• AEQUALIS REVERSED II46 models · 405 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