Aequalis™ Ascend™ Flex DWF602BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700386944512), received between Nov 9, 2017 and Apr 21, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Contamination” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT : "I HAVE A PATIENT WHO HAS A PROBLEM WITH A PLATE WHICH IS MOBILE ON THE SHAFT OF A REVERSE SHOULDER PROSTHESIS. CLINICAL CONTEXT: PERSISTENT PAINFUL EPISODE SINCE (B)(6) 2024 WITH NO IMPROVEMENT, OR EVEN DETERIORATION. THE ICONOGRAPHY SHOWS A CHANGE IN THE RELATIONSHIP BETWEEN THE GLENOSPHERE AND THE PLATINUM, SUGGESTING A PROBLEM WITH THE MORSE TAPER."

  Patient problems: Pain

  MAUDE report 21876453 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21534760 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL RESULTING IN A PERIPROSTHETIC FRACTURE. ALL IMPLANTED COMPONENTS WERE REMOVED, AND A REVERSE PROSTHESIS WAS PLACED. NO IMAGES WERE PROVIDED. THE EXPLANTED IMPLANTS WERE NOT AVAILABLE FOR EVALUATION PER HOSPITAL POLICY REQUIRING DISPOSAL OF EXPLANTED ITEMS.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 21242119 ↗
• InjuryNov 23, 2021Migration; Migration

  REVISION OF REVERSE SHOULDER ARTHROPLASTY. THE NON-CEMENTED HUMERAL STEM HAD MIGRATED LATERALLY SINCE INITIAL SURGERY. REVISION SURGERY FOR REMOVAL CONFIRMED IT WAS LOOSE AND NO BONE INGROWTH HAD OCCURRED. THERE WAS A QUESTION OF INFECTION AND THE SURGEON REVISED THE PATIENT WITH A WASHOUT OF SURGICAL SITE, IMPLANTATION OF NEW HUMERAL STEM WITH ANTI-BIOTIC CEMENT, REPLACEMENT OF GLENOSPHERE AND TREATMENT WITH INTRA AND POST-OPERATIVE ANTI-BIOTICS.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 12859586 ↗
• InjuryJul 27, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON THE (B)(6) 2020: THIS PATIENT UNDERWENT A ASCEND FLEX REVERSE SURGERY ON THE RIGHT SHOULDER . AFTER SURGERY, ON (B)(6) 2021, SHE HAD A MEDICAL CHECK UP AND A BONE FRACTURE WAS CONFIRMED ON THE AFFECTED PART. THE PATIENT FALL WAS THE CAUSE. THE REVISION WAS INITIALLY SCHEDULED FOR AROUND (B)(6) 2021 FOR LONG STEM REPLACEMENT. BUT THE REVISION SURGERY WAS PERFORMED ON (B)(6). THERE WAS NO REMOVAL OR REPLACEMENT OF THE IMPLANT, AND THE SURGERY WAS COMPLETED WITH OSTEOSYNTHESIS BY FIXATION USING A PLATE AND CABLE FROM ANOTHER COMPANY.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 12232384 ↗
• InjuryFeb 7, 2020Contamination; Contamination

  "WE NOTICED ON THE STEM, AFTER IMPACTING TRAY, WHITE BLOTCHY. DIDN'T RUB OFF. DECIDED TO OPEN A 3B STEM AFTER COMPACTING NEW SIZE. WHEN 3B STEM WAS OPENED WE NOTICED PLASTIC FLECKS ON THE STEM. WE WIPED THEM OFF AND IMPACTED THE TRAY ON THE NEW STEM. AFTER TRAY IMPACTION WE NOTICED THESE WHITE MARKS AGAIN ON BOTH SIDES OF THE STEM. WE DETERMINED THIS WAS AN ISSUE WITH THE IMPACTION BLOCK MWF107. THE 3B STEM WAS IMPLANTED. NO BACK UP AVAILABLE. HAD TO OPEN AND COMPACT FOR SIZE UP. NOT THE BEST SIZE AND FIT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9680602 ↗
• InjuryNov 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY/ DISLOCATION. HUMERAL COMPONENTS AND GLENOID SPHERE WERE CHANGED, + SAMPLE AND WASHING." PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7013160 ↗