Tornier Flex Shoulder System DWF603CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700434019728), received between Feb 25, 2022 and Oct 17, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "STUDY: SHOUT SUBJECT: (B)(6). INFECTION. PATIENT REQUIRED REVISION SURGERY."

  Patient problems: Unspecified Infection

  MAUDE report 20468788 ↗
• InjuryMay 2, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE STEM AND PYROCARBON HEAD DUE TO PAIN AND REDUCED RANGE OF MOTION. IMPLANT SHOWN TO BE IN AN UNSATISFACTORY POSITION.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 19235134 ↗
• InjuryMay 9, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 APRIL 2012 ¿ MAY 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE "ASEPTIC LOOSENING GLENOID/GLENOID IMPLANT WEAR/LYSIS - HUMERUS/LYSIS - GLENOID", WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE : "SINGLE STAGE REVISION.¿

  Patient problems: Osteolysis

  MAUDE report 16898406 ↗
• InjuryOct 17, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE COMPLICATION. PATIENT UNDERWENT COMPONENT REMOVAL. "EXCENTRATION OF THE HUMERAL PROSTHESIS WITH POSTERO SUPERIOR GLENOID WEAR WHICH LEAD TO SHOULDER PAINS AND MOTION LIMITATIONS."

  Patient problems: Failure of Implant; Implant Pain; Loss of Range of Motion

  MAUDE report 15620288 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION AT 15 DAYS POST-OP. ANTIBIOTHERAPY DURING 6 WEEKS. PATIENT ID : (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 13606750 ↗