Tornier Flex Shoulder System DWF605CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700434021479), received between Aug 22, 2022 and Aug 13, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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

  Patient problems: Subluxation; Unspecified Infection

  MAUDE report 22794921 ↗
• InjuryMay 30, 2023Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 BETWEEN (B)(6)2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2018 A PATIENT REQUIRED REVISION SURGERY DUE " INSTABILITY/ASEPTIC LOOSENING HUMERUS/NATIVE GLENOID SURFACE EROSION/DISLOCATION/SUBLUXATION", WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : "STAGE 1 OF 2 STAGE REVISION¿.

  Patient problems: Osteolysis

  MAUDE report 17020880 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT SUSTAINED WORK RELATED SHOULDER INJURY. THE PATIENT UNDERWENT SURGERY TO REPAIR THE ROTATOR CUFF TENDON TEAR. THERE WERE ONGOING COMPLAINTS OF PAIN AND POOR FUNCTION WHICH LED TO THE PATIENT UNDERGOING A SHOULDER HEMI-ARTHROPLASTY. THE PAIN AND POOR RANGE OF MOVEMENT CONTINUED. THE PATIENT WENT TO ANOTHER SURGEON FOR FURTHER ROTATOR CUFF PATHOLOGY DIAGNOSIS. THE SURGEON THAT THE PATIENT REQUIRES CONVERSION OF HEMI-ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY (RSA). THE STEM AND HEAD IMPLANTS WERE REMOVED WITHOUT DIFFICULTY. THE STEM WAS FIXED. A COMPETITOR RSA PROSTHESIS IMPLANTED

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 15265158 ↗