Tornier Flex Shoulder System DWF521Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700434020229), received between Dec 29, 2022 and Jul 3, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• InjuryJul 3, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A THIRD REVISION SHOULDER REPLACEMENT SURGERY PERFORMED ON A PATIENT WITH RECURRENT DISLOCATIONS. THIS WAS THE FOURTH SURGERY ON THE SAME SHOULDER. ALL HUMERAL COMPONENTS (STEM, TRAY, POLY) WERE REMOVED AND REPLACED: A 2B STANDARD STEM WAS REPLACED WITH A 3C STANDARD STEM, A HIGH OFFSET +6 TRAY WAS REPLACED WITH A HIGH OFFSET +12 TRAY, AND A FLEX REVERSED INSERT B +9 WAS REPLACED WITH A FLEX REVERSED INSERT B +9 RETENTIVE. THE GLENOID IMPLANTS WERE LEFT INTACT.

  Patient problems: Joint Dislocation

  MAUDE report 19671177 ↗
• InjuryJun 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS EVENT IS REPORTABLE TO REVISION SURGERY THAT THE PATIENT UNDERWENT ON THE SAME SHOULDER DUE TO RECURRENT DISLOCATIONS. THIS EVENT WILL BE FILED AS A SERIOUS INJURY. THIS MDR IS TO DOCUMENT THE SECOND REVISION SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 19596041 ↗
• InjuryMar 25, 2024Unstable; Device Dislodged or Dislocated; Unstable; 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION/INSTABILITY/ASEPTIC LOOSENING HUMERUS/DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Dislocation; Subluxation; Unspecified Infection

  MAUDE report 18967334 ↗
• InjuryFeb 29, 2024Device 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 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) 2020 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 18813060 ↗
• InjuryDec 29, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD SIGNIFICANT PAIN. FOLLOWING IMPLANT LOOSENING OR FAILURE, PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. REPORTS OF COMPLEX REGIONAL PAIN SYNDROME IN AUGUST 2020. IN MAY 2021 PATIENT'S X-RAYS REVEAL RADIOLUCENT LINES AND/OR BONY RESORPTION CONSISTENT WITH IMPLANT LOOSENING OR FAILURE. PATIENT CONTINUES TO HAVE SIGNIFICANT PAIN AND FUNCTIONAL LIMITATIONS IN SPITE OF NON OPERATIVE MANAGEMENT.

  Patient problems: Implant Pain

  MAUDE report 16069795 ↗