Aequalis™ Ascend™ Flex DWF604BRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03700386944574), received between Nov 16, 2016 and Jan 28, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024, A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24197583 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REVISION SURGERY WAS PLANNED TO BE PERFORMED USING THE BLUEPRINT PLANNING FEATURE. THE PATIENT IS 59 YEAR OLD FEMALE HAS RHEUMATOID ARTHRITIS AND HAD A SIGNIFICANT FALL AFTER SURGERY THAT RESULTED IN IMPLANT LOOSENING.

  Patient problems: Fall; Rheumatoid Arthritis

  MAUDE report 21393814 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A DEEP INFECTION 1 MONTH POST-OPERATIVE. PATIENT ID : (B)(6). (ONGOING ADVERSE EVENT ; MEDICAL TREATMENT WAS GIVEN TO THE PATIENT).

  Patient problems: Unspecified Infection

  MAUDE report 13606744 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT (B)(6) HAD A POST-OPERATIVE COMPLICATION DUE TO INFECTION (INTRAOPERATIVE CULTURES POSITIVE FOR C ACNES). ACTION TAKEN : MEDICATION, "IV ANTIBIOTICS MANAGED BY INFECTIOUS DISEASE". ON (B)(6) 2021: "PATIENT NOW ON ORAL ANTIBIOTICS".

  Patient problems: Unspecified Infection

  MAUDE report 12939547 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED DISLOCATION CARRYING A POT AND THEN SELF-REDUCTION. SUBJECT ID: (B)(6).

  Patient problems: Joint Dislocation

  MAUDE report 11265234 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN ACROMIAL FRACTURE (SCAPULAR SPINE STRESS FRACTURE) NOT PRESENT PRE-OP, 1 YEAR AFTER PRIMARY SURGERY. PATIENT ID: (B)(6)".

  Patient problems: Bone Fracture(s)

  MAUDE report 9882237 ↗
• 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 9705791 ↗
• InjuryNov 16, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY AT 3 MONTHS POST-OP DUE TO INSTABILITY/DISLOCATION. THE IMPLANTED STEM, REVERSED TRAY AND INSERT WERE REMOVED. BASEPLATE AND GLENOSPHERE REMAINED FROM PREVIOUS SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6105427 ↗