AEQUALIS REVERSED II DWD190Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 03700386935886), received between Aug 8, 2016 and Sep 21, 2026 — classified as 37 injuries, 3 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, 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 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 ↗
• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 23958155 ↗
• InjuryJan 5, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, DISLOCATION & SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Subluxation

  MAUDE report 23957840 ↗
• InjuryDec 2, 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 REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 23691659 ↗
• InjuryOct 9, 2025Device Dislodged or Dislocated; Device 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) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, ASEPTIC GLENOID LOOSENING, GLENOID LYSIS AND DISLOCATION/SUBLUXATION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Medical device site infection; Osteolysis; Subluxation

  MAUDE report 23255493 ↗
• InjuryAug 13, 2025Device Dislodged or Dislocated; Device 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) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/ SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 22792322 ↗
• InjuryAug 8, 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 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 22747635 ↗
• InjuryApr 22, 2025Device Dislodged or Dislocated; Device 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) 2025. 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: Joint Dislocation; Subluxation

  MAUDE report 21882509 ↗
• InjuryApr 4, 2025Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  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 FEBRUARY 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, GLENOID IMPLANT WEAR AND DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Subluxation

  MAUDE report 21772198 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY PATIENT REPORTS PAIN AND SWELLING."

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 21045851 ↗
• InjuryDec 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "SUBJECT: (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. SUBJECT NOTICED A SUDDEN INCREASE IN PAIN ON (B)(6) 2021, YET DID NOT SUFFER ANY ACCIDENT, INCIDENT, OR FALL. FOLLOW UP X-RAYS ON 18 AUG 2021 REVEALED AN ANTERIOR SUPERIOR REVERSE SHOULDER DISLOCATION. THE HUMERAL COMPONENTS WERE STILL STABLE AND THERE WAS A HINT OF BONE BRIDGING FROM THE NATIVE UPPER HUMERUS TO THE NATIVE LOWER HUMERUS ACROSS THE ALLOGRAFT. REVISION SURGERY ON (B)(6) 2021."

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 21036006 ↗
• InjuryAug 6, 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) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19918701 ↗
• InjuryJul 9, 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 (B)(6)2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19702259 ↗
• InjuryMar 27, 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 (B)(6) 2012 ON (B)(6) 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.

  Patient problems: Unspecified Infection

  MAUDE report 18987274 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE TORNIER SHOULDER OUTCOMES STUDY, A TRAUMATIC ACROMIAL FRACTURE OCCURRED POSTOPERATIVELY. THE ADVERSE EVENT RESOLVED WITHOUT SEQUELAE. IT WAS ASSESSED AS NOT RELATED TO THE STUDY DEVICE OR THE SURGICAL PROCEDURE. AN UPDATE NOTED THAT NO ACTION WAS TAKEN, AND NO TREATMENT WAS ADMINISTERED. DURING THE VISIT, GLENOID NOTCHING WAS OBSERVED, WITH THE NOTCH EXTENDING TO THE LOWER SCREW AND GLENOID LUCENCIES INVOLVING THE BASEPLATE (SUPERIOR OR INFERIOR).

  Patient problems: Bone Fracture(s)

  MAUDE report 18969300 ↗
• InjuryOct 10, 2023Adverse 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 (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : SINGLE STAGE REVISION.

  Patient problems: Implant Pain

  MAUDE report 17909367 ↗
• InjuryAug 22, 2023Naturally Worn; Naturally Worn

  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) 2019 A PATIENT REQUIRED REVISION SURGERY DUE STIFFNESS AND GLENOID IMPLANT WEAR, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion

  MAUDE report 17599372 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT (B)(6) UNDERWENT A REVISION SURGERY OF THE COMPLETE HUMERAL AND GLENOID SIDES DUE TO CALCIFIC PSEUDOTUMOR. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Seroma

  MAUDE report 16778832 ↗
• MalfunctionMar 14, 2023Mechanical Jam; Mechanical Jam

  THE GRUB SCREW OF THE GLENOSPHERE COULD NOT BE SCREWED; IT WAS TIGHT OR JAMMED AND THEREFORE COULD NOT BE SCREWED/SECURED INTO THE BASE PLATE. AS AN ALTERNATIVE, THE ECCENTRIC GLENOSPHERE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542253 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAIN IS TRAVELING AND IS SO SEVERE AT TIMES. ALL INTO NECK AND DOWN ARM. SURGERY IN 2016 GOT BETTER BUT 6 MONTHS AGO, MY ARM IS MUCH MORE PAINFUL. I HAVE 105 + 2 LOT OF MOBILITY IN IT. CAN'T AFFORD TO GO TO DR AND CHECKED. I AM ON. WAS DOING REALLY GOOD ON HEALING. 6 MONTHS AGO STARTED GETTING WEAKER. THE PAIN IS ALL THE WAY INTO NECK AND MY HAND IS NUMB AND TINGLING. ELBOW PAIN. CAN'T AFFORD TO GO TO DOCTOR.

  Patient problems: Pain

  MAUDE report 13606874 ↗
• MalfunctionFeb 25, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE SCREW WOULD NOT ENGAGE THE BASEPLATE (WHEN HE WENT TO SCREW, AFTER IMPACTING). THE CENTER SCREW KEPT SPINNING. THE GLENOID SPERE WAS LEFT IN PATIENT. DR. FELT THE SPHERE WAS STILL ATTACHED TO THE BASEPLATE IN A SOUND & SECURE FASHION.

  Patient problems: Failure of Implant

  MAUDE report 13606746 ↗
• InjuryMay 21, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO INSTABILITY POST REVERSE TOTAL SHOULDER REPLACEMENT (TORNIER THREADED POST BASEPLATE, SCREWS, GLENOSPHERE, TRAY AND INSERT REMOVED BY THE SURGEON IN DURANGO CO). TORNIER FLEX PTC 6B LONG STEM WAS REPORTED WELL FIXED BY THE SURGEON, SO RETAINED IN PATIENT. THE PATIENT WAS COMPLIANT TO MOBILIZATION INSTRUCTIONS OF THE SURGEON BUT NOT THE LONG TERM WEIGHT RESTRICTIONS. THE SURGEON DID NOT WANT TO PROVIDE THE CT SCANS. THE PATIENT WAS PULLING HOSES 9 MONTHS POST OP AND FELT A "POP" THAT WAS PRESUMABLY A DISLOCATION HE STATES, MULTIPLE SELF REPORTED DISLOCATIONS, NONE DOCUMENTED UNTIL LATE WINTER EARLY OF 2021. THE SURGEON WANTS TO MAKE SURE IT¿S CLEARLY UNDERSTOOD THAT HE HAS NO COMPLAINT AGAINST OUR PRODUCTS, JUST REPORTING AS ASKED OF A REVISION TOTAL SHOULDER. REVERSED INSERT WERE IMPLANTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 11866404 ↗
• InjurySep 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2020: THIS PATIENT BECAME PSEUDO-ARTICULATED AFTER A PROXIMAL HUMERUS FRACTURE AND HAD AN AEQUALIS REVERSE SURGERY. ON (B)(6) 2020: THE SURGEON FOUND A DISLOCATION BETWEEN THE INSERT AND THE GLENOID SPHERE. ON (B)(6) 2020: REVISION SURGERY WAS PERFORMED FOR THE REPLACEMENT OF THE INSERT AND THE GLENOID SPHERE. TO ADJUST THE TENSION, DWD989 AND DWD194, WERE NEWLY USED RESPECTIVELY. THE REMAINING IMPLANTS WERE TO CONTINUE TO BE USED AS THEY WERE.

  Patient problems: Joint Dislocation

  MAUDE report 10506681 ↗
• InjuryJul 7, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT WHO HAD AN INITIAL SURGERY OF THE AEQUALIS REVERSE ON (B)(6) 2015, VISITED THE OUTPATIENT DEPARTMENT ON (B)(6) 2020, AND COMPLAINED OF PAIN IN THE AFFECTED AREA. UPON X-RAY EXAMINATION AND PUNCTURE EXAMINATION OF THE AFFECTED AREA, LOOSENESS OF GLENOID IMPLANT AND INFECTION WERE CONFIRMED. SURGERY WAS PERFORMED ON (B)(6) 2020. SINCE THE BASE PLATE ON THE GLENOID SIDE WAS UNSTABLE, ALL IMPLANTS ON THE GLENOID SIDE WERE REMOVED EXCEPT THE HUMERAL STEM IMPLANT AND THE METAPHYSIS IMPLANT, AND THE SURGERY WAS COMPLETED. THE SURGEON COMMENTED:REGARDING THE IMPLANT ON THE HUMERAL SIDE WAS CONFIRMED TO BE STABLE, SO IT WAS LEFT AS IT WAS.

  Patient problems: Joint Dislocation; Pain; Unspecified Infection

  MAUDE report 10238773 ↗