Tornier Flex Shoulder System DWF602ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03700434021790), received between Mar 2, 2022 and Sep 21, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

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

  A revision surgery was performed as a result of a suspected infection after the patient fell.

  Patient problems: Fall; Post Operative Wound Infection

  MAUDE report 50841163 ↗
• InjuryNov 26, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND FRACTURED THE HUMERUS AND NEEDED A LONGER FRACTURE STEM TO REPLACE THE ORIGINAL STEM. THE GLENOID WAS UNAFFECTED. THE PATIENT UNDERWENT A REVISION SURGERY.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 23661111 ↗
• InjuryMar 5, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED BETWEEN (B)(6) 2022- (B)(6) 2023. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023 A PATIENT REQUIRED REVISION SURGERY DUE TO CUFF INSUFFICIENCY WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION (INCLUDES DAIR WITH MODULAR EXCHANGE AND MODULAR EXCHANGE FOR INDICATIONS OTHER THAN INFECTION).

  Patient problems: Damage to Ligament(s)

  MAUDE report 21529084 ↗
• 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 18245406 ↗
• InjuryNov 3, 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) 2017 A PATIENT REQUIRED REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: SINGLE STAGE REVISION.

  Patient problems: Limb Fracture

  MAUDE report 18065226 ↗
• InjurySep 15, 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 17760771 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PERIPROSTHETIC FRACTURE WITH COMPLETE DISPLACEMENT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE TORNIER FLEX STEM AND TORNIER POLY REVERSE TRAY REMOVED. REVIVE STEM PLACED WITH, WITH FLEX REVERSE TRAY, AND LATERALIZED INSERT.

  Patient problems: Limb Fracture

  MAUDE report 16291491 ↗
• 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 13651298 ↗