Tornier Flex Shoulder System DWF365BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700434022582), received between Jun 21, 2023 and Dec 2, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Unstable; Unstable

  THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO OTHER ADDITIONAL INFORMATION WAS RECEIVED FROM THE NATIONAL JOINT REGISTRY. MORE DETAILED INFORMATION ABOUT THE PATIENT'S MEDICAL HISTORY, THE EVENT DETAILS AND THE INVOLVED DEVICE(S) MUST BE AVAILABLE TO DETERMINE THE ROOT CAUSE. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED AND RE-EVALUATED ACCORDINGLY. PLEASE NOTE, THAT REPORTS RECEIVED FROM THE NATIONAL JOINT REGISTRY ARE NOT PUBLISHED REPORTS AND THEREFORE WEB LINK IS NOT AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 23691658 ↗
• InjuryDec 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "SUBJECT: (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY: SUBJECT NOTICED A SUDDEN INCREASE IN PAIN ON (B)(6) 2021, YET DID NOT SUFFER ANY ACCIDENT, INCIDENT, OR FALL. FOLLOW UP X-RAYS ON (B)(6) 2021 REVEALED AN ANTERIOR SUPERIOR REVERSE SHOULDER DISLOCATION. THE HUMERAL COMPONENTS WERE STILL STABLE AND THERE WAS A HINT OF BONE BRIDGING FROM THE NATIVE UPPER HUMERUS TO THE NATIVE LOWER HUMERUS ACROSS THE ALLOGRAFT. REVISION SURGERY ON (B)(6) 2021".

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 21035638 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT 008-00073 SHOUT - TORNIER SHOULDER OUTCOMES STUDY LEFT SHOULDER PAIN. SUBJECT EXPERIENCED INCREASED PAIN IN SHOULDER. THE CT SHOWED EARLY LOOSENING OF THE CENTRAL SCREW ON THE BASEPLATE. 2 STAGE-REVISION SURGERY:(B)(6) 2022 : SUBJECT UNDERWENT RESECTION ARTHROPLASTY WITH PLACEMENT OF ANTIBIOTIC SPACER (1ST STAGE REVISION) (B)(6) 2022 : IMPLANTATION OF REVIVE DUE TO SUBJECT EXPERIENCED INCREASED PAIN IN SHOULDER. THE CT SHOWED EARLY LOOSENING OF THE CENTRAL SCREW ON THE BASEPLATE (2ND STAGE REVISION)".

  Patient problems: Implant Pain; Inadequate Osseointegration

  MAUDE report 20804952 ↗
• InjuryJun 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE "REDUCTION OF THE INVERTED PROSTHESIS DISLOCATION BY EXTERNAL MANEUVER WITHOUT ANY DIFFICULTY. CLINICAL CONTROL OF MOBILITY. SCOPIC CONTROL OF THE REDUCTION." THE PATIENT UNDERWENT A SURGERY TO REMOVE THE IMPLANTS.

  Patient problems: Joint Dislocation; Loss of Range of Motion

  MAUDE report 17172574 ↗