Tornier Flex Shoulder System DWF151Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700434021707), received between Dec 19, 2023 and Feb 12, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Loss of Osseointegration

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER REPLACEMENT.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 MARCH 2023 - SEPTEMBER 2024. 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 GLENOID, GLENOID IMPLANT WEARLYSIS - HUMERUSLYSIS - GLENOID, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Osteolysis

  MAUDE report 24323470 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) SHOUT CLINICAL STUDY DEEP INFECTION. PATIENT IS HAVING SURGERY SCHEDULED FOR STAGE I EXPLANT AND TOTAL SHOULDER."

  Patient problems: Unspecified Infection

  MAUDE report 21122542 ↗
• InjurySep 5, 2024Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "PT UNDERWENT PRIMARY REVERSE SHOULDER REPLACEMENT ON (B)(6) 2024. DURING SURGERY, THE SURGEON WAS UNABLE TO COMPLETE THE SURGERY. BONE GRAFTING OF GLENOID BONE (USING PATIENT'S HUMERAL HEAD) UNDER GLENOID REV 2 BASEPLATE, WAS THE PLAN. BONE QUALITY, IN BOTH HUMERAL HEAD AND GLENOID, WAS FOUND TO BE VERY POOR/OSTEOPENIA. DURING IMPACTION OF BONE/PROSTHESIS CONSTRUCT ONTO PREPARED GLENOID SURFACE, THE GRAFT COLLAPSED, AND THE GLENOID VAULT WAS UNSUPPORTIVE / SOFT. SURGEON DECIDED TO ABANDON ORIGINAL PLAN, AND CONVERT TO A HEMI PROSTHESIS, & GRAFT THE GLENOID DEFECT, AS THE 1ST STAGE OF A NOW 2-STAGE PROCEDURE. DURING SURGERY ON (B)(6) 2024, HEMI HEAD REMOVED. GRAFTED GLENOID BONE WAS SOLID, ACCORDING TO SURGEON. MULTIPLE SPECIMENS TAKEN. PERFORM REVERSE GLENOID PROSTHESIS IMPLANTED, ALONG WITH ASCEND FLEX REVERSE TRAY AND POLY. PROSTHETIC SHOULDER JOINT REDUCED AND WAS STABLE THROUGH RANGE OF MOTION".

  Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis

  MAUDE report 20153641 ↗
• InjuryDec 19, 2023Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "A REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2023 BY THE SURGEON, USING THE BLUEPRINT PLANNING FEATURE (CASE ID: 0C0R0DM). REASON FOR REVISION WAS PROXIMAL MIGRATION OF THE HUMERUS DUE TO ROTATOR CUFF FAILURE OVER TIME."

  Patient problems: Inadequate Osseointegration

  MAUDE report 18355417 ↗