Aequalis™ Ascend™ Flex DWF602CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700386944529), received between Sep 12, 2019 and Sep 12, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2019Use of Device Problem; Use of Device Problem

  FOLLOWING THE SURGERY WHERE THESE ASCEND FLEX IMPLANTS (ANOTHER HOSPITAL IN (B)(6)) WERE IMPLANTED, IT WAS IDENTIFIED FROM A FOLLOW-UP SCAN THAT THE PYROCARBON HUMERAL HEAD HAD BEEN DAMAGED/CRACKED/SHATTERED. THIS PATIENT WAS REFERRED TO MR (B)(6) AT (B)(6). IT IS BELIEVED THAT THERE WERE METAL ANCHORS FROM A HISTORIC SOFT TISSUE PROCEDURE IN THE GLENOID AND THESE COULD POTENTIALLY HAVE BEEN A CONTRIBUTING FACTOR TO THE IMPLANT DAMAGE. MR (B)(6) HAD TO REMOVE EVERY PIECE OF THE IMPLANT (APPARENTLY THE INITIAL SURGEON PERFORMED AN ARTHROSCOPIC PROCEDURE AFTER IDENTIFYING THE ISSUE ON THE SCANS TO TRY REMOVE THE METAL ANCHORS). THE CARBON HAD DESTROYED MUCH OF THE PATIENT'S BONY ANATOMY AND A LOT OF THE SOFT TISSUES HAD TO BE DEBRIDED TO REMOVE THE CARBON AND CLEAN THE JOINT. A CEMENT SPACER WAS IMPLANTED AND IT IS EXPECTED A CUSTOM IMPLANT WILL BE REQUIRED TO REVISE THIS AT SOME POINT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9012272 ↗