FLEX SHOULDER SYSTEM DWF500Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03700386941030), received between Jul 7, 2016 and Dec 20, 2021 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2021Inaccurate Information; Inaccurate Information

  TODAY I HAD A WRONG IMPLANT IN A PACKAGE. THE PACKAGE INDICATED DWF510 AND IT SEEMED TO HAVE A DWF500 IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048760 ↗
• MalfunctionNov 10, 2021Inaccurate Information; Inaccurate Information

  IN SURGERY ON (B)(6) 2021 A BOX WAS OPENED FOR A CENTERED REVERSE TRAY +0. THE STICKERS ALL SAID CENTERED REVERSE +0 BUT THE IMPLANT WAS A 1.5MM EXCURSION TRAY +0. THE DOCTOR ENDED UP IMPLANTING THE 1.5MM EXCURSION TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12785653 ↗
• InjuryJul 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT HAD AN INSTABILITY/DISLOCATION ONE MONTH AFTER PRIMARY SURGERY. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. PATIENT ID: (B)(6)".

  Patient problems: Joint Dislocation

  MAUDE report 10216960 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISASSOCIATION OF THE DISTAL STEM AND THE PROXIMAL BODY OF AEQUALIS ASCEND FLEX REVIVE COMPONENTS VISUALIZED ON POST-OP X-RAY. PRELIMINARY ANALYSIS SHOWS THAT THE ISSUE IS NOT RELATED TO AEQUALIS ASCEND FLEX COMPONENTS BUT RATHER TO AEQUALIS FLEX REVIVE COMPONENTS DISASSOCIATION (TORNIER INC COMPONENTS).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9430523 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHEN THE PATIENT WAS SEEN BY THE SURGEON FOR HIS 2 WEEK FOLLOW UP APPOINTMENT THE X-RAY SHOWED THAT THE ASSEMBLY SCREW HAD STARTED TO BACK OUT AND THE PROXIMAL BODY WAS DISASSOCIATING FROM THE DISTAL STEM FROM A DEVICE OF ANOTHER LEGAL MANUFACTURER. THEREFORE, ASCEND FLEX REVERSED TRAY AND REVERSED INSERT THAT WERE ASSEMBLED ONTO THE DEVICE FROM OTHER LEGAL MANUFACTURER WERE EXPLANTED AS A CONSEQUENCE OF THE EXPLANTATION OF THE DEVICE FROM THE OTHER LEGAL MANUFACTURER. THE EXPLANTATION OF THE AEQUALIS ASCEND FLEX COMPONENTS IS THE CONSEQUENCE OF THE EXPLANTATION OF THE DEVICE COMPONENTS OF THE OTHER LEGAL MANUFACTURER.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9079528 ↗
• InjuryDec 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT HAD AN INSTABILITY/DISLOCATION 2 MONTHS POST-OPERATIVE. SUBJECT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8178391 ↗
• InjuryDec 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSED REDUCTION UNDER ANESTHESIA DUE TO INSTABILITY/DISLOCATION, 3 MONTHS POST-OPERATIVE. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8159454 ↗
• InjuryJul 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY FOR LOOSENING/LYSIS AT 10 MONTHS POST-OPERATIVE. PATIENT ID: (B)(6)".

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7694209 ↗
• InjuryFeb 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT WOKE UP WITH ANTERIOR DISLOCATION -TREATED WITH CLOSED REDUCTION ON (B)(6) 2015. THIS PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY/DISLOCATION 2 MONTHS POST-OPERATIVE. PATIENT ID : (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7285263 ↗
• InjuryMar 23, 2017Adverse 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 AT 15 MONTHS POST-OPERATIVE DUE TO LOOSENING/LYSIS. REVISION FOR CHANGING HUMERAL COMPONENTS ONLY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6427262 ↗
• InjuryJan 13, 2017Adverse 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 FRACTURE. BASEPLATE REMAINED FROM PREVIOUS SURGERY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6248992 ↗
• InjuryDec 22, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY AT 14 MONTHS POST-OPERATIVE FOR INSTABILITY/DISLOCATION. STEM AND BASEPLATE REMAINED IMPLANTED FROM PREVIOUS SURGERY. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6197756 ↗
• InjuryNov 21, 2016Adverse 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 TO FRACTURE. THE IMPLANTED STEM, REVERSED TRAY AND INSERT WERE REMOVED. BASEPLATE AND GLENOSPHERE REMAINED FROM PREVIOUS SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED FOR THIS PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6116586 ↗
• 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 5774687 ↗