Tornier Flex Shoulder System DWF392BRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03700434020502), received between Jan 10, 2022 and Sep 17, 2026 — classified as 14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Adverse 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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)2026.During the review of the report, it was identified that on (b)(6)2026 a patient required revision surgery due to infection & lysis- glenoid, which was not previously reported to the manufacturer.

  Patient problems: Unspecified Infection

  MAUDE report 50803904 ↗
• InjuryMar 3, 2026Adverse 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 24494188 ↗
• InjuryJan 26, 2026Unstable

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity

  MAUDE report 24176413 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT LEFT REVERSE SHOULDER REPLACEMENT ON (B)(6) 2025. PT EXPERIENCED A VERY POSITIVE POST-OP REHAB / RECOVERY, DEMONSTRATING (ACCORDING TO THE SURGEON) A FULL RANGE OF MOTION OF HIS PROSTHETIC SHOULDER JOINT, WITHIN 6 WEEKS POST-OP. LATER, PATIENT WAS RIDING A PUSH BIKE (IN THE EARLY HOURS OF THE MORNING), AND FELL OFF, DISLOCATING HIS LEFT SHOULDER JOINT. UNABLE TO BE CLOSED REDUCED. SURGEON DECIDED ON A MUA, BOOKED FOR (B)(6) 2025. JOINT REDUCED, UNDER ANESTHESIA, BUT GROSSLY UNSTABLE.SURGEON DECIDED ON AN OPEN PROCEDURE. TORNIER FLEX REVERSED 0MM TRAY WAS REMOVED, ALONG WITH THE TORNIER REVERSED INSERT 39MM/9MM, AND A THICKER TRAY (6MM) AND (SAME SIZE) NEW INSERT WERE IMPLANTED. ON REDUCTION, THE JOINT WAS STILL UNSTABLE. SURGEON DISLOCATED THE JOINT, REMOVED THE NEW REVERSE TRAY / POLY INSERT, AND PROCEEDED TO EXPLORE FOR FURTHER CAUSES OF THE IMPINGEMENT / INSTABILITY. MORE POSTERO-INFERIOR GLENOID BONE WAS REMOVED. THE (PRIMARY) IMPLANTED 39MM STANDARD GLENOSPHERE WAS THEN REMOVED, REPLACED BY A 42MM STANDARD GLENOSPHERE. THE SUPERIOR GLENOID 30MM SCREW WAS FOUND TO BE LOOSE, AND REPLACED WITH A 34MM SCREW. A NEW 12MM FLEX REVERSE TRAY

  Patient problems: Fall; Subluxation

  MAUDE report 24066673 ↗
• InjuryDec 24, 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 WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED UNTIL (B)(6) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 23886905 ↗
• InjuryDec 10, 2025Unstable; 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 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 ON (B)(6) 2025 A PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, DISLOCATION & SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 23768661 ↗
• InjuryJul 9, 2025Unstable; Unstable

  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) 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION & INSTABILITY, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. STAGE 1 OF 2 STAGE REVISION.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 22456100 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INFECTION, UNRELATED TO THE PROSTHESIS, AND AS SUCH A REVISION SHOULDER REPLACEMENT WAS PERFORMED AND GLENOID, HUMERAL TRAY AND POLY WERE EXCHANGED. PATIENT'S INFECTION WAS CAUSED BY OTHER CONDITIONS.

  Patient problems: Unspecified Infection

  MAUDE report 22321322 ↗
• InjuryFeb 24, 2025Device 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 OF THE SHOULDER REPLACEMENT. THE REPORT DETAILS ANALYSIS PROVIDED FOR REVISION PROCEDURES PERFORMED UNTIL (B)(6) 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION AND SUBLUXATION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: REVISION STEMMED TOTAL REVERSE ARTHROPLASTY.

  Patient problems: Subluxation

  MAUDE report 21452880 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS SCHEDULED, USING THE BLUEPRINT PLANNING FEATURE . THE PATIENT DEVELOPED AN INFECTION, AND THE SURGEON REMOVED ALL IMPLANTS, INCLUDING TORNIER'S FLEX STEM AND PERFORM REVERSE GLENOID SYSTEMS, AND REPLACED THEM WITH AN ANTIBIOTIC SPACER. THERE WERE NO COMPLICATIONS IN REMOVING THE IMPLANTS AND PLACING THE ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 20397403 ↗
• InjurySep 10, 2024Adverse 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 (B)(6) 2012 ¿ (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2022 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER. REVISION PROCEDURE TYPE: DEBRIDEMENT AND IMPLANT RETENTION (DAIR).

  Patient problems: Unspecified Infection

  MAUDE report 20179172 ↗
• InjuryAug 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE IMPLANT WAS DISLOCATING. THE POLY AND TRAY WERE REMOVED, BONE FRAGMENTS WERE TIDIED UP AND AN ATTEMPT WAS MADE TO REMOVE THE STEM. THE STEM WAS WELL FIXED, AND IT WAS DECIDED TO LEAVE THIS IN SITU AND A NEW TRAY AND THICKER POLY WERE ADDED.

  Patient problems: Joint Dislocation

  MAUDE report 19950489 ↗
• 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 (B)(6)2012 ¿ (B)(6) 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 18812565 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TWO YEARS AFTER PRIMARY STUDY SURGERY DUE TO INFECTION. THE STEM, TRAY AND INSERT WERE REMOVED, AS WELL AS REVERSED BASEPLATE AND GLENOSPHERE. FIRST STAGE OF A 2-STAGE SURGERY: REVISED TO ANTIBIOTIC CEMENT HEMI.

  Patient problems: Unspecified Infection

  MAUDE report 13211648 ↗