Tornier Flex Shoulder System DWF361CRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03700434021004), received between Mar 2, 2022 and Sep 21, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fall; Post Operative Wound Infection

  MAUDE report 50841156 ↗
• InjuryMar 9, 2026Device Dislodged or Dislocated

  A PATIENT ENCOUNTERED A DISLOCATION, IN WHICH THE JOINT WAS SUBSEQUENTLY REDUCED UNDER SEDATION.

  Patient problems: Joint Dislocation

  MAUDE report 24546901 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF HUMERAL COMPONENTS DUE TO PERIPROSTHETIC FRACTURE CAUSE BY PATIENT FALL. THE HUMERAL COMPONENTS WERE REMOVED, AND REPLACED WITH A AEQUALIS FLEX REVIVE STEM, THE FRACTURE REDUCED TO THIS REVISION STEM. NO ISSUE WITH IMPLANTS.

  Patient problems: Fall; Limb Fracture

  MAUDE report 20292674 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PRIMARY REVERSE SHOULDER REPLACEMENT (RIGHT SIDE) PERFORMED IN (B)(6) 2022. PATIENT HAD COMPLAINED OF SIGNIFICANT PAIN FOR MANY RECENT MONTHS, WITH INABILITY TO MOVE HER PROSTHETIC SHOULDER (JOINT). REVISION SURGERY WAS PERFORMED WHERE ALL IMPLANTS WERE REMOVED AND A COMPETITOR RSA PROSTHESIS WAS IMPLANTED. SURGEON COMMENTED THAT THE GLENOID BASEPLATE, AUGMENTED WITH APPROXIMATELY 10MM OF BONE GRAFT DURING THE PRIMARY SURGERY, HAD OVER-LATERALISED THE GLENO-HUMERAL JOINT LINE, LEADING TO THE PAIN / REDUCED RANGE OF MOTION."

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 18246600 ↗
• InjurySep 18, 2023Migration; Migration

  IN THE TORNIER SHOULDER OUTCOMES STUDY, A RADIOGRAPH REPORT NOTED A NOTCH EXTENDING TO A LOWER SCREW. THE ISSUE WAS MANAGED WITH CONSERVATIVE CARE. THERE HAVE BEEN NO ADDITIONAL FOLLOW-UP VISITS FOR THIS PATIENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17770462 ↗
• InjurySep 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE CASE OF THE SHOUT SUBJECT, AN ACROMIAL FRACTURE WAS OBSERVED POSTOPERATIVELY, EVEN THOUGH IT WAS NOT PRESENT BEFORE THE SURGERY. THE SUBJECT REPORTED EXPERIENCING PAIN RADIATING FROM THE LATERAL ASPECT OF THE ARM INTO THE NECK AND THE BACK OF THE SCAPULA. A CT SCAN CONFIRMED THE PRESENCE OF AN ACROMIAL STRESS FRACTURE. THE ISSUE WAS ULTIMATELY RESOLVED WITH SEQUELAE.

  Patient problems: Bone Fracture(s); Implant Pain

  MAUDE report 17762350 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFERED WITH INFECTION. THE PATIENT WAS REVISED AND IMPLANTED WITH CEMENT ANTIBIOTIC SPACER.

  Patient problems: Bacterial Infection

  MAUDE report 16924440 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A POST OPERATIVE ADVERSE EVENT THAT INCLUDED SEVERE SHOULDER PAIN AND LOSS OF CONSCIOUSNESS THAT RESULTED IN THE FALL ONTO THE OPERATED SHOULDER AND LOSS OF MEMORY.

  Patient problems: Implant Pain; Loss of consciousness; Memory Loss/Impairment

  MAUDE report 15712542 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ULNAR NERVE TUNNEL SYNDROME AND SEVERE PAIN POST-OPERATIVE.

  Patient problems: Nerve Damage; Pain

  MAUDE report 13651304 ↗