AEQUALIS REVERSED II DWH904Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03700386955075), received between Nov 5, 2019 and Jul 28, 2026 — classified as 7 injuries, 2 malfunctions.

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.

• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  A revision was performed due to infection.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50054842 ↗
• InjurySep 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, USING THE BLUEPRINT PLANNING FEATURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23175402 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT HAD PRIMARY LEFT SHOULDER REPLACEMENT ON (B)(6) 2022. THE PATIENT COMPLAINED OF PAIN, HAD ARTHROSCOPIC DEBRIDEMENT ON (B)(6) 2024, THE SPECIMENS TAKEN SHOWED INFECTED WITH C. ACNES BACTERIUM. MULTIPLE ARTHROSCOPIC WASHOUTS / DEBRIDEMENT PROCEDURES, WITH INSERTION OF ANTIBIOTIC BEADS INTO JOINT SPACE AND LONG-TERM ANTIBIOTIC THERAPY, WITH LAST PROCEDURE ON (B)(6) 2025. FURTHER SPECIMENS TAKEN DURING THIS PROCEDURE SHOWED PERSISTENT C. ACNES INFECTION, THOUGH SCANT. DURING THIS PROCEDURE, THE SURGEON MADE THE INTRA-OPERATIVE DECISION, TO REMOVE ALL PRIMARY IMPLANTS AND INSERT A ANTIBIOTIC SPACER, & CONTINUE ANTIBIOTIC (IV AND ORAL) THERAPY, AND HAVE A 2ND STAGE JOINT REPLACEMENT PROCEDURE IN THE FOLLOWING MONTHS, WHEN ALL CLINICAL MARKERS INDICATE THE INFECTION IS ABSENT.

  Patient problems: Bacterial Infection

  MAUDE report 22512138 ↗
• InjuryJan 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2024, USING THE BLUEPRINT PLANNING FEATURE. THE PATIENT WAS REVISED DUE TO REPORTED DISLOCATION AND PAIN.

  Patient problems: Implant Pain

  MAUDE report 21160026 ↗
• MalfunctionMar 13, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE IT WAS IMPOSSIBLE TO SCREW THE GLENOSPHERE ON THE BASEPLATE. THE SCREW TURNED FREELY. THE PHYSICIAN CHANGED THE GLENOSPHERE TWICE BUT THEY BOTH HAD THE SAME ISSUE. THE PROCEDURE COULD BE COMPLETED CORRECTLY BY CHANGING THE GLENOSPHERE STYLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534703 ↗
• MalfunctionMar 13, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE IT WAS IMPOSSIBLE TO SCREW THE GLENOSPHERE ON THE BASEPLATE. THE SCREW TURNED FREELY. THE PHYSICIAN CHANGED THE GLENOSPHERE TWICE BUT THEY BOTH HAD THE SAME ISSUE. THE PROCEDURE COULD BE COMPLETED CORRECTLY BY CHANGING THE GLENOSPHERE STYLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534649 ↗
• InjuryJun 6, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT REVERSE SHOULDER IMPLANTED IN APPROXIMATELY 2019. THE GLENOID BASEPLATE COMPONENT OF THE SYSTEM BECAME LOOSE OVER TIME. THE GLENOID COMPONENT OF THE SYSTEM WAS REMOVED WITHOUT ISSUE AND THE IMPLANT WAS CONVERTED TO A HEMI SHOULDER WITH THE POLY REMOVED ON THE HUMERAL SIDE AND REPLACED WITH A CONVERTOR AND HUMERAL HEAD.

  Patient problems: Inadequate Osseointegration; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605975 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE INITIAL SURGERY FOR ASCEND FLEX REVERSE WAS PERFORMED. AFTER THIS SURGERY, THE AFFECTED AREA WAS FOUND TO BE INFECTED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020. AFTER CLEANING THE AFFECTED AREA, ONLY THE GLENOID SPHERE WAS REPLACED WITH THE SAME PRODUCT NUMBER AND THE SURGERY WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 10288146 ↗
• InjuryNov 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "(B)(6) 2019: THE FIRST SURGERY OF ASCEND FLEX RSA WAS PERFORMED. (B)(6) 2019: AFTER THE SURGERY, DISLOCATION OCCURRED IN THE AFFECTED AREA."

  Patient problems: Joint Dislocation

  MAUDE report 9278764 ↗