FLEX SHOULDER SYSTEM DWF143Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386940163), received between Jan 5, 2017 and Dec 1, 2025 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN (B)(6) 2025 - (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO UNEXPLAINED PAIN, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Pain

  MAUDE report 23687352 ↗
• InjuryMay 6, 2020Adverse 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 5 MONTHS AFTER INITIAL SURGERY, DUE TO INFECTION. THE PATIENT ALSO HAD A HUMERAL FATIGUE FRACTURE DURING THE REVISION SURGERY. PATIENT ID: (B)(6).

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 10028425 ↗
• InjuryMar 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FEELS SHOULDER IS GOING TO POP OUT OF PLACE. PATIENT STATED IT TENDS TO HAPPEN SEVERAL TIMES A DAY. PATIENT THINKS SHOULD MAY POP OUT THE BACK OF THE SOCKET. X-RAY SHOWS SOME BONE RESORPTION, POSSIBLE STRESS SHIELDING AROUND PROXIMAL ASPECT OF THE HUMERUS, LUCENCY AROUND CENTRAL POST. CT SCAN ORDERED TO EVALUATE POSSIBLE GLENOID LOOSENING. PATIENT ID: (B)(6).

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7344614 ↗
• InjuryJan 5, 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 ROTATOR CUFF INSUFFICIENCY. CONVERSION TO REVERSE SHOULDER ARTHROPLASTY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6224612 ↗