AEQUALIS REVERSED DWD126Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03700386917097), received between Aug 26, 2019 and Aug 19, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A SHOULDER REVISION WAS PLANNED ON (B)(6) 2025 FOR INFECTION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22373289 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A SHOULDER REVISION WAS PLANNED ON (B)(6) 2025 FOR INFECTION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 22373284 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18903035 ↗
• InjuryDec 29, 2023Osseointegration Problem; Osseointegration Problem

  TORNIER SHOULDER OUTCOMES STUDY - SHOUT ((B)(6)). LOOSENING OF THE GLENOID COMPONENT BECAUSE OF A FALL DOWN OF THE PATIENT, GENERATING A GLENOID FRACTURE. DATE OF EXPLANT: (B)(6) 2019. RESOLVED WITHOUT SEQUELAE: (B)(6) 2019. UPDATE: ACCORDING TO THE ATTACHED REPORTS AND AN HCP REVIEW, ONE OF THE 32MM SCREWS WAS BROKEN. IT IS UNKNOWN WHICH ONE.

  Patient problems: Bone Fracture(s); Fall; Inadequate Osseointegration

  MAUDE report 18419285 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SHOULDER REPLACEMENT PERFORMED. THE PATIENT REPORTED OOZING OF WOUND POST-PROCEDURE. EXPLORATION SURGERY AND CULTURE REVEALED INFECTION. THE FIRST STAGE OF THE REVISION WAS COMPLETED WITH A WASH OUT.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 15815880 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SHOULDER REPLACEMENT. THE PATIENT REPORTED OOZING OF THE WOUND POST-PROCEDURE. AN EXPLORATION SURGERY AND CULTURE REVEALED THE PRESENCE OF AN INFECTION. THE FIRST STAGE OF THE REVISION WAS COMPLETED WITH A WASH OUT.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 15815275 ↗
• InjuryJul 21, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER REPLACEMENT 10 YEARS AGO. ALLEGEDLY, THE PATIENT PRESENTED WITH PAIN AND A REVISION WAS SCHEDULED. DURING THE REVISION THE SITE APPEARED INFECTED. INVESTIGATIONS DONE AND BONE SCAN SHOWED HOT SPOT OVER THE GLENOID WHILE X RAY DEMONSTRATED GLENOID LOOSENING. GLENOID COMPONENT WAS LOOSE AND MEDIALISED AND ONE SCREW HAD BROKEN. GLENOID IMPLANT REMOVED, ALONG WITH THE POLY FROM THE HUMERAL COMPONENT. CULTURES TAKEN. CONVERTED TO A HEMI.

  Patient problems: Failure of Implant; Implant Pain; Unspecified Infection

  MAUDE report 15075887 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF PRIMARY REVERSE SHOULDER REPLACEMENT. REMOVAL OF ALL COMPONENTS DUE TO SUSPICION OF INFECTION IN GLENOID AND REPLACEMENT WITH ANTI-BIOTIC CEMENT SPACER IN HUMERUS. NOTICED BY SURGEON DURING ROUTINE FOLLOW UP.

  Patient problems: Unspecified Infection

  MAUDE report 12861777 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF PRIMARY REVERSE SHOULDER REPLACEMENT. REMOVAL OF ALL COMPONENTS DUE TO SUSPICION OF INFECTION IN GLENOID AND REPLACEMENT WITH ANTI-BIOTIC CEMENT SPACER IN HUMERUS. NOTICED BY SURGEON DURING ROUTINE FOLLOW UP.

  Patient problems: Unspecified Infection

  MAUDE report 12861772 ↗
• InjuryNov 10, 2021Difficult to Remove; Difficult to Remove

  DURING A REVERSE SHOULDER REPLACEMENT, THE SURGEON ATTEMPTED TO REMOVE THE 4 SCREWS INSERTED INTO THE GLENOID BASEPLATE (REF (B)(4)) TO ADJUST THE POSITION OF THIS BASEPLATE AS THE BONE GRAFT WAS REPORTED TO BE LOOSENED. 3 SCREWS WERE REMOVED SUCCESSFULLY BUT THE 4TH MULTI-DIRECTIONAL SCREW (REF (B)(4)) WAS NOT ABLE TO BE BACKED OUT. DURING THE PROCESS OF ATTEMPTING TO REMOVE THIS SCREW, IT WAS REPORTED THAT THE GLENOID FRACTURED AND THE BASEPLATE CAME OUT. THE SURGEON PROCEEDED TO CONTINUE THE OPERATION BY SWITCHING TO A LONG POST BASEPLATE. THE LONGER BASEPLATE WAS NOT ABLE TO BE INSERTED AND THE SURGEON DECIDED TO SWITCH TO A HEMI USING THE AEQUALIS HUMERAL HEAD.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 12785998 ↗
• InjuryApr 22, 2021Break; Break

  REVISION OF AN ASCEND FLEX/ REVERSED FOR A PROBLEM ON THE GLENOID SIDE, ON (B)(6) 2021. PATIENT STARTED TO BE PAINFUL IN (B)(6) 2020 (I.E. ROUGHLY 6 YEARS AFTER INITIAL SURGERY IN (B)(6) 2014). LOSS OF ROM WAS ALSO NOTED. THE X-RAYS SHOWED 3 BROKEN PERIPHERAL SCREWS.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11705805 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT HAD AN INITIAL SURGERY OF AEQUALIS REVERSE AT (B)(6) ORTHOPEDICS HOSPITAL. ON (B)(6) 2020, AN INFECTION WAS FOUND AT THE AFFECTED PART AT THE SAME HOSPITAL. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED AT (B)(6) MEDICAL CENTER. AFTER REMOVING ALL THE IMPLANTS,THE MOLD CEMENT WHICH INCLUDES ANTIBIOTICS WAS IMPLANTED TO THE HUMERAL AND THE SURGERY WAS COMPLETED. AFTER SEVERAL MONTHS OF FOLLOW-UP, ANOTHER REVISION SURGERY MIGHT BE PERFORMED FOR NEW IMPLANTS DEPENDING ON THE RECOVERY SITUATION.

  Patient problems: Unspecified Infection

  MAUDE report 10475811 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THIS PATIENT HAD AN INITIAL SURGERY OF AEQUALIS REVERSE AT (B)(6) ORTHOPEDICS HOSPITAL. ON (B)(6) 2020, AN INFECTION WAS FOUND AT THE AFFECTED PART AT THE SAME HOSPITAL. ON (B)(6) 2020, A REVISION SURGERY WAS PERFORMED AT (B)(6) MEDICAL CENTER. AFTER REMOVING ALL THE IMPLANTS,THE MOLD CEMENT WHICH INCLUDES ANTIBIOTICS WAS IMPLANTED TO THE HUMERAL AND THE SURGERY WAS COMPLETED. AFTER SEVERAL MONTHS OF FOLLOW-UP, ANOTHER REVISION SURGERY MIGHT BE PERFORMED FOR NEW IMPLANTS DEPENDING ON THE RECOVERY SITUATION.

  Patient problems: Unspecified Infection

  MAUDE report 10475809 ↗
• 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 10238772 ↗
• 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 10238770 ↗
• InjuryAug 26, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  SCREW IMPLANTED AS PART OF A ASCEND FLEX REVERSE ON (B)(6) 2018. PATIENT HAD DISCOMFORT AND GLENOID LOOSENING (UNSURE AS TO EXACT DATE). X RAYS REVEALED INFERIOR LOCKING SCREW HAD SNAPPED.

  Patient problems: Injury; Patient Problem/Medical Problem

  MAUDE report 8930652 ↗
• InjuryAug 26, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  SCREW IMPLANTED AS PART OF A ASCEND FLEX REVERSE ON (B)(6) 2018. PATIENT HAD DISCOMFORT AND GLENOID LOOSENING (UNSURE AS TO EXACT DATE). X RAYS REVEALED INFERIOR LOCKING SCREW HAD SNAPPED.

  Patient problems: Injury; Patient Problem/Medical Problem

  MAUDE report 8930651 ↗
• InjuryAug 26, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  SCREW IMPLANTED AS PART OF A ASCEND FLEX REVERSE ON (B)(6) 2018. PATIENT HAD DISCOMFORT AND GLENOID LOOSENING (UNSURE AS TO EXACT DATE). X RAYS REVEALED INFERIOR LOCKING SCREW HAD SNAPPED.

  Patient problems: Injury; Patient Problem/Medical Problem

  MAUDE report 8930649 ↗