Tornier Flex Shoulder System DWF364BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03700434022612), received between Mar 23, 2023 and Jun 8, 2026 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Device 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 FOR THE MONTHLY REPORT OF MAY 2026. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 25426872 ↗
• InjuryOct 20, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 IMPINGEMENT, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Impingement

  MAUDE report 23335091 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT: (B)(6) REVIVE HRS STUDY. PATIENT SEEN FOR SWELLING AND PAIN OF RIGHT SHOULDER (OPERATED SHOULDER) ACCORDING TO THE SURGEON, THIS EVENT IS NOT RELATED TO THE DEVICE OR THE SURGERY.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 22663547 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY PATIENT REPORTS PAIN AND SWELLING."

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 21045848 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE TORNIER SHOULDER OUTCOMES STUDY, A TRAUMATIC ACROMIAL FRACTURE OCCURRED POSTOPERATIVELY. THE ADVERSE EVENT RESOLVED WITHOUT SEQUELAE. IT WAS ASSESSED AS NOT RELATED TO THE STUDY DEVICE OR THE SURGICAL PROCEDURE. AN UPDATE NOTED THAT NO ACTION WAS TAKEN, AND NO TREATMENT WAS ADMINISTERED. DURING THE VISIT, GLENOID NOTCHING WAS OBSERVED, WITH THE NOTCH EXTENDING TO THE LOWER SCREW AND GLENOID LUCENCIES INVOLVING THE BASEPLATE (SUPERIOR OR INFERIOR).

  Patient problems: Bone Fracture(s)

  MAUDE report 18969299 ↗
• InjuryMar 23, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY/DISLOCATION OF THE IMPLANT. PRIMARY SURGERY WAS CONDUCTED 3 DAYS POST-OP THE PATIENT HAD INSTABILITY/DISLOCATION OF THE IMPLANT (X-RAY CONTROL: PTEI CAT DISLOCATION. REDUCTION / IMMOBILIZATION BY ABDUCTION CUSHION ON THE SAME DAY) 4 MONTHS LATER THERE WAS RECURRENCE OF PROSTHETIC DISLOCATION: REPEAT WITH GLENOSPHERE. PATIENT UNDERWENT A REVISION SURGERY 4 DAYS LATER WITH REVISION OF THE INSERT AND GLENOSPHERE. RESOLVED WITH SEQUELAE (X-RAY 5 YEARS AFTER REVISION).

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 16603915 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE CONSULTATION FOR THE CLINICAL REASSESSMENT OF A PAINFUL RIGHT SHOULDER, ABOUT 4 AND A HALF MONTHS FROM THE IMPLANTATION OF A REVERSED TOTAL SHOULDER PROSTHESIS. THE CURRENT EVOLUTION IS MORE RELATED TO A LOW NOISE EVOLUTION INFECTION THAN A PAIN SYNDROME, AS INITIALLY SUSPECTED. THE CONTROL OF THE SCAR OF THE DAY IS INDEED INFLAMMATORY, WITH A SWELLING SUGGESTING POSSIBLE FISTULIZATION OF THE SKIN INFECTION. PRIMARY SURGERY WAS CONDUCTED, 5 MONTHS LATER INFECTION WAS DETECTED. 6 MONTHS AFTER PRIMARY SURGERY THE PATIENT UNDERWENT A REVISION WITH IMPLANT REMOVAL AND ANTIBIOTICS. ONE YEAR POST-OP THE EVENT RESOLVED WITHOUT SEQUELAE.

  Patient problems: Implant Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16600259 ↗