Aequalis™ Ascend™ Flex DWF603BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03700386944543), received between Oct 18, 2018 and Dec 29, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2018 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 23905585 ↗
• InjuryDec 1, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 PERIPROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 23687373 ↗
• InjuryOct 9, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, ASEPTIC GLENOID LOOSENING, GLENOID LYSIS AND DISLOCATION/SUBLUXATION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Medical device site infection; Osteolysis; Subluxation

  MAUDE report 23255295 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OPERATIVE COMPLICATION : INFECTION RE-OPERATION WITH COMPONENT CHANGE ON THE (B)(6) 2021 (NO INFORMATION REGARDING THE EXACT DEVICES REMOVED). IV ANTIBIOTICS, CEMENT ANTIBIOTIC SPACER ADDED.

  Patient problems: Unspecified Infection

  MAUDE report 12297942 ↗
• InjurySep 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT INITIAL RSA ON (B)(6) 2017. THE IMPLANTS USED WERE ASCEND FLEX STD PTC HUMERAL STEM (DWF603B), REVERSE INSERT (DWF362B), REVERSE TRAY (DWF520), REVERSED II DIA. 25 PRESS FIT POST BASE PLATE (DWD170) AND REV. II GLENOID SPHERE DIA. 25 BASE PLATE (DWD180). ON (B)(6) 2017, A DISLOCATION OCCURED AND REVISION SURGERY WAS PERFORMED. DURING THIS SURGERY, TRAY (DWF520), INSERT (DWF391B), AND SPHERE (DWH905) WERE NEWLY USED. IN 2019 (NO DATE), DISLOCATION OCCURRED AGAIN AND MANUAL REDUCTION WAS PERFORMED, BUT A REVISION SURGERY WAS TO BE PERFORMED AGAIN. (B)(6) 2019, REVISION SURGERY WAS PERFORMED: ASCEND FLEX: LONG PTC HUMERAL STEM 4B 132.5 ° 104MM (DWF614B), REVERSED INSERT 42MM (+) 9 B-12.5 (DWF425B), REV. II GLENOID SPHERE DIA. 25 BASEPLATE DIA. 42MM 10 TILTED SPHERE (DWD184), ASCEND FLEX REVERSED TRAY (+) 0 1.5MM (DWF510) WERE NEWLY REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 9079532 ↗
• InjuryOct 18, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGERY WITH SMALL TUBEROSITY OSTEOTOMY (ANTERIOR IMPINGEMENT OF THE PROSTHESIS WITH THE CONJOINT TENDON). THE PROSTHESIS WAS NOT TOUCHED BY THE SURGEON. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7978030 ↗