Tornier Flex Shoulder System DWH146Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03700434021318), received between Aug 22, 2023 and Mar 10, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN 2020 - 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON 13 MAY 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO CUFF INSUFFICIENCY, STIFFNESS AND NATIVE GLENOID SURFACE EROSION , WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Damage to Ligament(s); Erosion; Loss of Range of Motion

  MAUDE report 24560663 ↗
• InjuryJan 13, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO NATIVE GLENOID SURFACE EROSION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Erosion

  MAUDE report 24051253 ↗
• InjuryJan 5, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE ANKLE JOINT REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN 2022 - 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 23957859 ↗
• InjuryAug 4, 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 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 STIFFNESS, NATIVE GLENOID SURFACE EROSION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Erosion

  MAUDE report 22697841 ↗
• InjuryMay 26, 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 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 ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS AND NATIVE GLENOID SURFACE EROSION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Erosion; Loss of Range of Motion

  MAUDE report 22083346 ↗
• InjuryAug 22, 2023Adverse 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 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 STIFFNESS AND UNEXPLAINED PAIN, EVENT WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 17600395 ↗