AEQUALIS REVERSED DWD120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03700386917080), received between Feb 7, 2019 and Jan 7, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION AFTER SHOULDER REPLACEMENT SURGERY. PAIN WAS ALSO REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22794926 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF REVERSE II GLENOID AND POLY LINER. THE GLENOID COMPONENT HAD BROKEN AWAY FROM THE GLENOID. THE GLENOSPHERE AND BASEPLATE HAD DISSOCIATED AND THERE WAS POLY WEAR. THE IMPLANTS WERE REMOVED AND REPLACED. A SCREW WAS USED TO REMOVE THE POLY LINER.

  Patient problems: Insufficient Information

  MAUDE report 18862181 ↗
• 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 18419282 ↗
• MalfunctionDec 9, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT A RSA WAS PERFORMED. BASE PLATE WAS PLACED ON THE SCAPULAR SIDE, AFTER INSERTION OF THREE LOCKING SCREWS, A 20-MM LENGTH LOCKING SCREW WAS INSERTED AS A FORTH SCREW. WHEN THE SURGEON CHECKED THAT SCREW BECAUSE IT WAS NOT MATING WELL WITH THE BASE PLATE, THE SURGEON FOUND THAT THE LOCKING THREADS WERE UNEVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950557 ↗
• 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 11705800 ↗
• InjuryFeb 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE INITIAL SURGERY ON THE LEFT SHOULDER WAS HELD ON (B)(6) 2018. THE BASE PLATE WAS DISLOCATED ON (B)(6) 2019, AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. ON (B)(6) THE FRACTURE OF THE GLENOID CAVITY DUE TO DISLOCATION WAS CONFIRMED DURING REVISION SURGERY. THE BONE GRAFT WAS DONE IN THE GLENOID CAVITY, AND THE HUMERUS SIDE WAS TREATED WITH A CEMENT TYPE CONTAINING ANTIBIOTICS. AFTER ABOUT SIX MONTHS FOLLOW-UP, THE SURGEON WILL DECIDE WHETHER TO REPLACE THE BASE PLATE WHILE WATCHING THE RECOVERY STATUS OF THE BONE.

  Patient problems: Joint Dislocation

  MAUDE report 8315278 ↗
• InjuryFeb 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE INITIAL SURGERY ON THE LEFT SHOULDER WAS HELD ON (B)(6) 2018. THE BASE PLATE WAS DISLOCATED ON (B)(6) 2019, AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. ON (B)(6), THE FRACTURE OF THE GLENOID CAVITY DUE TO DISLOCATION WAS CONFIRMED DURING REVISION SURGERY. THE BONE GRAFT WAS DONE IN THE GLENOID CAVITY, AND THE HUMERUS SIDE WAS TREATED WITH A CEMENT TYPE CONTAINING ANTIBIOTICS. AFTER ABOUT SIX MONTHS FOLLOW-UP, THE SURGEON WILL DECIDE WHETHER TO REPLACE THE BASE PLATE WHILE WATCHING THE RECOVERY STATUS OF THE BONE.

  Patient problems: Joint Dislocation

  MAUDE report 8315275 ↗