Tornier Flex Shoulder System DWF046Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03700434022520), received between Jul 20, 2023 and Mar 19, 2025 — classified as 8 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. 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.

• InjuryMar 19, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM.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 BETWEEN DECEMBER 2013 ¿ FEBRUARY 2024. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2023, A PATIENT REQUIRED REVISION SURGERY DUE TO STIFFNESS, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Loss of Range of Motion

  MAUDE report 21644283 ↗
• InjuryFeb 26, 2025Device Dislodged or Dislocated; Osseointegration Problem; Device Dislodged or Dislocated; Osseointegration 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT.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 UNTIL FEBRUARY 2025. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2024 A PATIENT REQUIRED REVISION SURGERY DUE TO CUFF INSUFFICIENCY, ASEPTIC LOOSENING OF GLENOID AND DISLOCATION/SUBLUXATION WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Inadequate Osseointegration; Subluxation

  MAUDE report 21470075 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ADVERSE EVENT: : PATIENT EXPERIENCING PAIN. DIAGNOSED WITH ROTATOR CUFF FAILURE POST ARTHROPLASTY. REQUIRED INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT OR DAMAGE. : YES. ORIGINAL SURGERY ¿ (ANATOMIC CONFIGURATION) DATE OF IMPLANT: (B)(6) 2014. ¿ STEM ¿ AEQUALIS ASCEND FLEX 4A STANDARD PTC HUMERAL STEM. ¿ HUMERAL HEAD- ASCEND FLEX STANDARD LOW OFFSET 46 X17 AEQUALIS (HUMERAL INDEX 6.5). ¿ GLENOID ¿ PERFORM- PEGGED M35. REVISION IMPLANTS ¿ (REVISION TO REVERSED CONFIGURATION) DATE OF REVISION SURGERY: (B)(6) 2024. ¿ STEM- RETAINED. EXPLANTATION OF THE FOLLOWING DEVICE COMPONENTS: ¿ HUMERAL HEAD- ASCEND FLEX STANDARD LOW OFFSET 46 X17 AEQUALIS (HUMERAL INDEX 6.5). ¿ GLENOID ¿ PERFORM- PEGGED M35. IMPLANTATION OF THE FOLLOWING DEVICE COMPONENTS: ¿ TRAY- HIGH OFFSET TRAY +0MM. ¿ INSERT- STANDARD 36 DIA. (+) 6MM/7.5C. ¿ GLENOID- BASEPLATE- PERFORM REVERSED GLENOID- LATERALIZED BASEPLATE (+3MM), 25MM. ¿ GLENOID- GLENOSPHERE- STANDARD 36MM DIAMETER".

  Patient problems: Implant Pain; Muscle/Tendon Damage

  MAUDE report 19607495 ↗
• InjuryNov 10, 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) 2020 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 18110708 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION CASE OF A TOTAL ANATOMIC TO A REVERSE SHOULDER. IMPLANTS REMOVED HUMERAL HEAD AND GLENOID PEGGED IMPLANT. THE PATIENT HAD A BIG FALL AND THEN AFTER THAT, THE GLENOID IMPLANT LOOSENED AND PATIENT NEEDED REVISION SURGERY DUE TO HER MUSCLES FAILING." THE GLENOID IMPLANT HAD COMPLETELY LOOSENED AND WAS NO LONGER IN THE CORRECT SPOT. IT WAS FLOATING LOOSE ON THE PATIENTS JOINT AND SHE HAD PAIN AND HENCE NEEDED THE REVISION SURGERY. "

  Patient problems: Fall; Implant Pain

  MAUDE report 17990363 ↗
• InjurySep 18, 2023Loss of Osseointegration; Loss of Osseointegration

  IN THE TORNIER SHOULDER OUTCOMES STUDY , THE PATIENT EXPERIENCED ROTATOR CUFF DEFICIENCY AND EXTENSIVE GLENOID BONE LOSS IN THEIR LEFT SHOULDER. THIS CONDITION WAS ASSESSED AS POSSIBLY RELATED TO BOTH THE STUDY DEVICE AND THE SURGICAL PROCEDURE. THE ADVERSE EVENT OUTCOME IS ONGOING, AND THE PATIENT IS USING THC CREAM AND HYDROCODONE 10/325 MG FOR PAIN RELIEF. NOTABLY, THE LEFT SHOULDER DID NOT HAVE A GLENOID IMPLANT; INSTEAD, ISOLATED REAMING/SHAPING AND THE USE OF AN ALLOGRAFT (SKAFFOLD) WERE EMPLOYED.

  Patient problems: Osteolysis; Pain

  MAUDE report 17770469 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH AN ANTERIOR GLENOHUMERAL MASS. THE PATIENT ALSO PRESENTED WITH SWELLING IN THE FRONT OF THE SHOULDER. MRI REVEALED A MASS. THE SUBJECT WAS REFERRED OUT TO AN ORTHOPEDIC ONCOLOGIST.

  Patient problems: Seroma; Swelling/ Edema

  MAUDE report 17385906 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING HETEROTOPIC OSSIFICATION. THE PATIENT'S SHOULDER HAS SOME LATERAL CORTEX DEFORMITY AND OSTEOLYSIS ALONG THE LATERAL METAPHYSEAL SECTION OF THE COMPONENT WITH SUPERIOR HUMERAL MIGRATION AND SEVERE GLENOID EROSION.

  Patient problems: Erosion; Swelling/ Edema

  MAUDE report 17366788 ↗