FLEX SHOULDER SYSTEM DWF361CRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03700386940514), received between Aug 8, 2016 and Aug 28, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VISIT DATE ON (B)(6) 2018 (ONSET DATE OF ADVERSE EVENT: (B)(6) 2017) POST-OPERATIVE COMPLICATION: HUMERAL FRACTURE / INJURY (TRAUMATIC) TRAUMA ON LEFT SHOULDER : 1 SCREW BROKEN AND LOOSENING OF GLENOÏD. NO SURGICAL PROCEDURE AT THAT TIME. (B)(6) 2018: REVISION SURGERY FOR IMPLANT BREAKAGE ON THE GLENOID SIDE.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 10464817 ↗
• 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)(4)."

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8159455 ↗
• 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 8159453 ↗
• InjuryAug 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "IT WAS REPORTED THAT A PATIENT UNDERWENT A CLOSED REDUCTION FOR INSTABILITY/DISLOCATION 7 MONTHS POST-OPERATIVE. PATIENT ID : (B)(6)."

  Patient problems: Joint Dislocation; Patient Problem/Medical Problem

  MAUDE report 7796939 ↗
• InjuryFeb 7, 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 6 MONTHS POST-OPERATIVE DUE TO LOOSENING/LYSIS. REVISION FOR CHANGING HUMERAL COMPONENTS ONLY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6307308 ↗
• InjuryAug 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POST-OPERATIVE INSTABILITY-DISLOCATION (ANTERIOR). PROBLEM RESOLVED WITHOUT SEQUELAE BY CLOSED REDUCTION. (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5853181 ↗