AEQUALIS REVERSED II DWD182Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 03700386935848), received between Jul 28, 2017 and Sep 18, 2026 — classified as 18 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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 ↗
• InjuryMay 21, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IN 1ST REVISION, GLENOSPHERE AND STEM REPLACED DUE TO DISLOCATION. PRIOR TO STRYKER ACQUISITION OF TORNIER/ WRIGHT.

  Patient problems: Joint Dislocation

  MAUDE report 22064742 ↗
• InjuryApr 3, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 UNTIL (B)(6) 2025. 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 21766638 ↗
• InjuryMar 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A REVISION SURGERY DUE TO SHOULDER DISLOCATION AND RELATED PAIN OCCURRED. IT WAS REPORTED THAT: "DURING THE REVISION SURGERY, THE SURGEON REALIZED THAT THE 45 PERCENT OF THE MISMATCH COUVERTURE WAS INSUFFICIENT."

  Patient problems: Joint Dislocation; Pain

  MAUDE report 21576552 ↗
• InjuryMar 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A REVISION SURGERY DUE TO SHOULDER DISLOCATION AND RELATED PAIN OCCURRED. IT WAS REPORTED THAT: "DURING THE REVISION SURGERY, THE SURGEON REALIZED THAT THE 45 PERCENT OF THE MISMATCH COVERTURE WAS INSUFFICIENT."

  Patient problems: Joint Dislocation; Pain

  MAUDE report 21561889 ↗
• InjuryFeb 26, 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 UNTIL FEBRUARY 2025. 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. REVISION PROCEDURE TYPE: REVISION STEMMED TOTAL REVERSE ARTHROPLASTY.

  Patient problems: Joint Laxity

  MAUDE report 21469076 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT HAD DELTOID MUSCLE DYSFUNCTION".

  Patient problems: Loss of Range of Motion

  MAUDE report 20298645 ↗
• InjuryApr 1, 2024Device 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 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/DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: DEBRIDEMENT AND IMPLANT RETENTION (DAIR).

  Patient problems: Joint Dislocation; Subluxation; Unspecified Infection

  MAUDE report 19011615 ↗
• InjuryJan 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "REVERSE SHOULDER ARTHROPLASTY WAS PERFORMED FOR LEFT SHOULDER OF AN 83 YEARS OLD PATIENT. AFTER THE SURGERY, THE PATIENT HAD NOT VISITED THE HOSPITAL FOR A LONG TIME AND FOLLOW-UP INVESTIGATION COULD NOT BE PERFORMED ALL OF THAT TIME. ON (B)(6) 2023, THE PATIENT VISITED AND DISLOCATION OF THE AEQUALIS REVERSED GLENOSPHERE FROM THE BASE PLATE WAS CONFIRMED IN THE FOLLOW-UP INVESTIGATION. THE REVISION SURGERY TO REPLACE THE DEVICES WAS PERFORMED ON (B)(6) 2023."

  Patient problems: Implant Pain; Insufficient Information; Joint Dislocation

  MAUDE report 18460107 ↗
• InjuryNov 3, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "SURGERY BEGINS AT THE CLINIC FOR A REVIEW OF TOTAL SHOULDER REPLACEMENT. THE SURGERY BEGINS NORMALLY AND IT IS PLANNED TO CHANGE THE GLENOSPHERE AND THE INSERT. ONCE THE GLENOSPHERE THAT THE PATIENT HAD IS REMOVED, THE NEW MEDICAL DEVICE IS CIRCULATED, ONCE THE CENTRAL SCREW IS GOING TO BE RELEASED IT DOES NOT GIVE MOVEMENT, THE SPECIALIST TRIES TO RELEASE IT AND IT IS NOT POSSIBLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065114 ↗
• MalfunctionFeb 9, 2023Use of Device Problem; Mechanical Jam; Use of Device Problem; Mechanical Jam

  IT WAS REPORTED THAT THERE WAS A GLENOSPHERE DEFECT. ANOTHER IMPLANT WAS USED TO TREAT THE PATIENT. NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16343726 ↗
• InjuryNov 11, 2022Adverse 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 A SUSPECTED INFECTION OF THE GLENOID IMPLANT IN RSA PATIENT. THE INFECTION HAS BEEN CONFIRMED. ALL IMPLANTS EXCEPT THE PLUGS HAVE BEEN REMOVED, BUT PRODUCT DETAILS ARE UNKNOWN. SPACERS CREATED WITH CEMENT WERE FILLED IN.

  Patient problems: Unspecified Infection

  MAUDE report 15781348 ↗
• MalfunctionJul 20, 2021Mechanical Jam; Mechanical Jam

  WE COULD NOTICED THAT THE SAFETY SCREW OF THE GLENOSPHERE IS BLOCKED, LIKE WELDED AS SOON AS THE IMPLANT WAS UNPACKED. IT WAS IMPOSSIBLE FOR ME TO UNBLOCK IT, AS WELL AS THE SURGEON WHO IS VERY FAMILIAR WITH OUR IMPLANTS. PROCEDURE COMPLETED WITH A SECOND GLENOSPHERE. SURGICAL DELAY : 20MIN.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200642 ↗
• MalfunctionNov 24, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE FIRST GLENOSPHERE COULDN'T BE SCREWED, AND THE SECOND GLENOSPHERE THE CONNECTING SCREW WAS TIGHT. THE SURGEON USED A THIRD GLENOSPHERE AND THIS ONE WORKED. BY THIS ISSUE THE INTERVENTION TOOK ABOUT 30 MINUTES LONGER.

  Patient problems: Failure of Implant

  MAUDE report 10895000 ↗
• MalfunctionNov 24, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE SCREW COULD NOT BE TIGHTENED. ANOTHER GLENOSPHERE WAS OPENED. THE DELAY WAS APPROXIMATELY OF 30 MINUTES.

  Patient problems: Failure of Implant

  MAUDE report 10894949 ↗
• MalfunctionNov 24, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE FIRST GLENOSPHERE COULDN'T BE SCREWED, AND THE SECOND GLENOSPHERE THE CONNECTING SCREW WAS TIGHT. THE SURGEON USED A THIRD GLENOSPHERE AND THIS ONE WORKED. BY THIS ISSUE THE INTERVENTION TOOK ABOUT 30 MINUTES LONGER.

  Patient problems: Failure of Implant

  MAUDE report 10894916 ↗
• InjuryOct 1, 2020Device Difficult to Setup or Prepare; Mechanical Jam; Device Difficult to Setup or Prepare; Mechanical Jam

  DURING THE SURGICAL PROCEDURE WHEN THE DOCTOR REQUESTED THE 10° TILTED SPHERE (REFERENCE (B)(4), SERIAL NUMBER (B)(4)), THE MEDICAL DEVICE HAD THE SCREW BLOCKED, PREVENTING ITS PROPER IMPLANTATION TO THE THREADED POST BASEPLATE (REFERENCE (B)(4), SERIAL NUMBER (B)(4)). THE SURGEON TRIED TO RELEASE THE SCREW SEVERAL TIMES WITHOUT SUCCESS. THE DOCTOR SANCHEZ DECIDES APPLY FOR THE ECCENTRIC GLENOID SPHERE (REFERENCE (B)(4), SERIAL NUMBER (B)(4)) TO IMPLANT IT THE PATIENT, BUT HAD THE SAME PROBLEM, THE MEDICAL DEVICE HAD THE SCREW BLOCKED. THE SURGEON DECIDES TO INSERT THE CENTERED GLENOID SPHERE, (REFERENCE (B)(4), SERIAL NUMBER (B)(4)). THE SURGERY ENDS WITHOUT SERIOUS EVENTS, AND THE PATIENT DOES NOT HAVE ANY PROBLEM OR SERIOUS IMPACT. THIS EVENT IMPLIED THAT THE ANESTHESIA TIME WAS EXTEND FOR A PERIOD OF 40 MINUTES.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10612219 ↗
• InjuryJul 28, 2020Migration; Migration

  REVISION SURGERY DUE TO LOCAL REACTION AND MIGRATION OF THE PROSTHESIS (BROAD HUMERAL LYSIS AND MIGRATION). THE BONE SCINTIGRAPHY SHOWED SIGNS OF MOBILIZATION OF PROSTHESIS. DURING THE SURGICAL PROCEDURE FOR EXPLANT, PRESENCE OF LOCAL METALLOSIS (SAMPLES SENT FOR ANATOMICAL EXAMINATION AND MICROBIOLOGICAL). ALL THE COMPONENTS WERE REMOVED.

  Patient problems: Foreign Body Reaction

  MAUDE report 10331716 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "(B)(6) 2017: THE INITIAL SURGERY OF ""AEQUALIS REVERSE"" AND ""AEQUALIS ASCEND FLEX REVERSE"" WERE PERFORMED. (B)(6) 2018: THERE WAS A LEG FRACTURE. (B)(6) 2019: THE AFFECTED AREA GOT DISLOCATED AND THE REVISION SURGERY WAS SCHEDULED. (B)(6) 2020: THE REVISION SURGERY WAS PERFORMED. ALL THE IMPLANTS WERE REMOVED EXCEPT THE STEM, AND THE HEAD IMPLANT (DWF043) WAS NEWLY ATTACHED TO THE STEM. THE ILIAC BONE WAS IMPLANTED INTO THE GLENOID CAVITY, AND THE OPERATION WAS COMPLETED. THE SURGEON COMMENTED. ""AFTER THE FRACTURE OF THE LOWER LEG, WE RECOMMENDED TO MOVE ON A WHEELCHAIR THAT DID NOT APPLY A LOAD FROM BELOW, BUT THIS WAS PROBABLY DUE TO THE USE OF A WALKER AT THE REQUEST OF THE PATIENT. THERE WAS NO PROBLEM WITH THE IMPLANT.""

  Patient problems: Joint Dislocation

  MAUDE report 9705792 ↗
• InjuryFeb 6, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  DURING TOTAL ARTHROPLASTY SURGERY, THE SURGEON WAS NOT ABLE TO IMPACT THE GLENOID SPHERE ON THE BASEPLATE (IMPOSSIBILITY TO SCREW THE SPHERE). SECOND TRY WITH ANOTHER GLENOID ECCENTRIC SPHERE (SAME REFERENCE - (B)(4) - OTHER BATCH NUMBER: 0993AV001). AGAIN, THE GLENOID SPHERE COULD NOT BE SCREWED. USE OF A THIRD GLENOID SPHERE (CENTERED) WITH ANOTHER SCREWDRIVER TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9675532 ↗
• InjuryFeb 6, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  DURING TOTAL ARTHROPLASTY SURGERY, THE SURGEON WAS NOT ABLE TO IMPACT THE GLENOID SPHERE ON THE BASEPLATE (IMPOSSIBILITY TO SCREW THE SPHERE). SECOND TRY WITH ANOTHER GLENOID ECCENTRIC SPHERE (SAME REFERENCE - (B)(4) - OTHER BATCH NUMBER: 0993AV001). AGAIN, THE GLENOID SPHERE COULD NOT BE SCREWED. USE OF A THIRD GLENOID SPHERE (CENTERED) WITH ANOTHER SCREWDRIVER TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9675530 ↗
• InjuryJan 7, 2020Material Fragmentation; Inadequacy of Device Shape and/or Size; Material Fragmentation; Inadequacy of Device Shape and/or Size

  TIP OF THE SCREWDRIVER GRIPPED IN THE GLENOSPHERE. DELAY HAS BEEN 30 MINUTES. IN ONE OF THE GLENOSPHERES THE TIP OF THE SCREWDRIVER REMAINED. IT BROKE WHILE TRYING TO UNSCREW IT ON THE TABLE, WE HAD A SECOND SCREWDRIVER TIP IN THE INSTRUMENTS. INADEQUATE SIZE IMPLANT TO COMPLETE THE CASE. PATIENT ENDED WITH 42 HEAD SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9558319 ↗
• MalfunctionDec 4, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  CENTER LOCKING SCREW OF SPHERES WERE LOCKED IN SPHERES. COULD NOT RELEASE THE SCREW IN ANY DIRECTION. 60 MINUTES DELAYED.

  Patient problems: Failure of Implant

  MAUDE report 9410140 ↗
• InjuryJul 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE SURGERY WHEN THE SURGEON REQUESTED THE GLENOID SPHERE FOR IMPLANTATION, REFERENCE DWD182 SERIAL NUMBER 0531AS011, THE MEDICAL DEVICE HAD THE SCREW BLOCKED, PREVENTING ITS PROPER IMPLEMENTATION TO THE BASE PLATE. THE SURGEON TRIED SEVERAL TIMES TO RELEASE THE SCREW UNTIL THE 3.5 MM HEXAGONAL SCREWDRIVER TIP BROKE. THE DOCTOR TRIED TO IMPLANT OTHER SPHERE DWD181 SERIAL NUMBER 5951AR013 WITH A NEW 3.5 MM HEXAGONAL SCREWDRIVER BUT HAD THE SAME PROBLEM AND THE 3.5 MM HEXAGONAL SCREWDRIVER TIP BROKE AGAIN.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6749741 ↗