Tornier Flex Shoulder System DWH043Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03700434019469), received between May 9, 2023 and Sep 18, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 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  The manufacturer received a report from the National Joint Registry that contains unpublished collected data on the usage and the outcomes of the shoulder joint replacement.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 (b)(6) 2026.During the review of the report, it was identified that on (b)(6)2026 a patient required revision surgery due to native glenoid surface erosion & unexplained pain, which was not previously reported to the manufacturer.

  Patient problems: Erosion

  MAUDE report 50813793 ↗
• InjurySep 8, 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  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF THE SHOULDER JOINT REPLACEMENT.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 A PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION/SUBLUXATION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Subluxation

  MAUDE report 22993199 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT UNDERWENT SHOULDER HEMI-ARTHROPLASTY ON (B)(6) 2023, FOR FRACTURE PROXIMAL RIGHT HUMERUS. PATIENT HAS EXPERIENCED PAIN AND REDUCED RANGE OF MOTION OVER RECENT MONTHS. SURGEON SUSPECTS JOINT IS INFECTED, DUE TO 1 X SWAB RETURNING POSITIVE FOR BACTERIA C.ACNES. SURGEON HAS DECIDED ON A 2-STAGE REVISION ARTHROPLASTY. HUMERAL PROSTHESIS REMOVED, WITH SIGNIFICANT DIFFICULTY (HUMERAL STEM WELL FIXED). MULTIPLE TISSUE SPECIMENS TAKEN. EXPLANTED PROSTHESIS DISCARDED. CEMENT ANTIBIOTIC SPACER IMPLANTED."

  Patient problems: Bacterial Infection; Implant Pain; Loss of Range of Motion

  MAUDE report 19105750 ↗
• InjuryOct 23, 2023Naturally Worn; Naturally Worn

  AS REPORTED: "AN ASCEND FLEX PYROCARBON HEAD WAS REVERSED TO A TOTAL ANATOMICAL CONSTRUCT. THE PYROCARBON HEAD WAS REMOVED EASILY AND WITH MINIMAL WEAR. REVISION PROCEDURE." UPDATED: REPORTED PATIENT COMPLAINT WAS PAIN. ASCEND FLEX STANDARD HEAD WITH PERFORM GLENOID HAS BEEN REIMPLANTED. IT WAS A LEFT SIDE SHOULDER.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 17988950 ↗
• InjuryMay 9, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A SCREW FROM A PRIOR SURGERY RUBBING AGAINST PYROCARBON HUMERAL HEAD CAUSING DAMAGE TO THE HUMERAL HEAD. THE SURGEON REMOVED THE HUMERAL HEAD AND SWITCHED TO A FLEX REVERSE CONSTRUCT BECAUSE THE GLENOID WAS STRONGLY ANTEVERTED AND THEREFORE HE THOUGHT THAT AN ANATOMICAL ONE WOULD NOT HAVE BEEN STABLE.

  Patient problems: Insufficient Information

  MAUDE report 16898427 ↗