Aequalis™ Ascend™ Flex DWF606BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386944635), received between Jun 15, 2017 and Dec 22, 2025 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, REVISION SURGERY WAS PERFORMED. 2 STAGE PROCEDURE AS LIKELY TO BE INFECTED. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2022 WITH ASCEND FLEX AND REVERSE II IMPLANTS. ALL IMPLANTS WERE REMOVED AND PICTURED. A CEMENT SPACER WAS PLACED IN.IT WAS FURTHER REPORTED, THE PATIENT HAD PAIN AND SURGEON ORDERED X-RAYS (THESE WERE ATTACHED IN MY SUBMISSION) AND SURGEON NOTICED BONE REABSORPTION. DID NOT EXPECT INFECTION AS NO PATHOLOGY TESTS INDICATED IT. HOWEVER IN REVISION SURGEON THERE WAS STRONG EVIDENCE OF INFECTION WITH PUS AND INFECTED TISSUE.

  Patient problems: Implant Pain; Osteolysis; Unspecified Infection

  MAUDE report 23870699 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE ROTATOR CUFF INSUFFICIENCY, 2 YEARS AFTER PREVIOUS SURGERY. SUBJECT ID: (B)(6)".

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 9755931 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY DUE TO INFECTION 5 MONTHS AFTER PRIMARY SURGERY, AFTER HAVING REPORTED STIFFNESS AND PAIN WITH GENTLE RANGE OF MOTION. PATIENT ID: (B)(6)".

  Patient problems: Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 9465272 ↗
• MalfunctionJun 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY/DISLOCATION. STEM, TRAY AND INSERT WERE REMOVED AND REPLACED DURING SURGERY, BASEPLATE AND GLENOSPHERE REMAINED THE SAME FROM PREVIOUS SURGERY (1ST STAGE).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6642652 ↗