Aequalis™ Ascend™ Flex DWF601BRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03700386944482), received between Jul 7, 2016 and Jan 5, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 5, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, PERIPROSTHETIC FRACTURE & LYSIS- GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Bone Fracture(s); Osteolysis; Unspecified Infection

  MAUDE report 23957850 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR 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 IMPINGEMENT & LYSIS - GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION (INCLUDES DAIR WITH MODULAR EXCHANGE AND MODULAR EXCHANGE FOR INDICATIONS OTHER THAN INFECTION)

  Patient problems: Joint Impingement; Osteolysis

  MAUDE report 23886846 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2020: ASCEND FLEX REVERSE SURGERY WAS PERFORMED. LATELY IN (B)(6) 2020: SIGNS OF INFECTION WERE FOUND AFTER THE SURGERY. (B)(6) 2021: REVISION SURGERY WAS PERFORMED. ALL THE IMPLANTS WERE REMOVED, THE AFFECTED PART WAS CLEANED, THE SPACER MADE BY CEMENT WAS IMPLANTED, AND THE SURGERY WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 12142351 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020: ASCEND FLEX REVERSE SURGERY WAS PERFORMED. LATELY IN (B)(6) 2020: SIGNS OF INFECTION WERE FOUND AFTER THE SURGERY. ON (B)(6) 2021: REVISION SURGERY WAS PERFORMED. ALL THE IMPLANTS WERE REMOVED, THE AFFECTED PART WAS CLEANED, THE SPACER MADE BY CEMENT WAS IMPLANTED, AND THE SURGERY WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 11705804 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AFTER THIS PATIENT HAD A ASCEND FLEX REVERSE SURGERY ON (B)(6) 2020, A DISLOCATION OCCURRED AT THE AFFECTED AREA. ON (B)(6) 2020, AN IMPLANT AT THE AFFECTED AREA WAS REPLACED AND THE SURGERY WAS FINISHED.

  Patient problems: Joint Dislocation; Joint Disorder

  MAUDE report 10249649 ↗
• InjuryDec 4, 2018Adverse 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 FOR PERSISTENT SHOULDER PAIN. PATIENT ID: (B)(64).

  Patient problems: Pain

  MAUDE report 8128331 ↗
• InjuryNov 17, 2017Missing Value Reason; Missing Value Reason

  PARTIAL RESORPTION OF THE GREATER TUBEROSITY (VERY MODERATE, BETWEEN THE TRAY AND THE STEM). PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7040376 ↗
• InjuryJul 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY FOR LOOSENING. PATIENT HAD BONE SCAN CONSISTENT WITH HUMERAL LOOSENING BUT ONLY MINIMAL SYMPTOMS. FOLLOWED CLINICALLY AND RETURNED 3 MONTHS AFTER INITIAL DISCOVERY OF POTENTIAL LOOSENING DECIDED TO REVISE IMPLANT. (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5774682 ↗