Tornier Flex Shoulder System DWF424BRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700434019704), received between Oct 2, 2024 and Jan 10, 2025 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). SHOUT - TORNIER SHOULDER OUTCOMES STUDY. CONSIDERABLE ONGOING LEFT SHOULDER PAIN AND INCREASING LEFT AXILLARY PAIN. NO INJURY. ON (B)(6) 2021, SUBJECT FIRST REPORTED CONSIDERABLE LEFT SHOULDER PAIN. X-RAYS AND PHYSICAL EXAM WERE NORMAL WITHOUT ANY EVIDENCE OF COMPLICATION. HE WAS INSTRUCTED TO RETURN IN 1 YEAR FOR ANNUAL FOLLOW UP. ON (B)(6) 2022, HE REPEATED THESE COMPLAINTS. YET AGAIN, X-RAYS DID NOT REVEAL EVIDENCE OF LOOSENING. SURGEON ATTEMPTED ASPIRATION TO SEND FOR CULTURE BUT WAS UNABLE TO OBTAIN ANY FLUID. SUBJECT WAS SENT FOR CBC, ESR, AND CRP LABS. SURGEON THOUGHT INFECTION WAS UNLIKELY BUT WANTED TO INVESTIGATE ALL POTENTIAL CAUSES FOR ONGOING PAIN. ON (B)(6) 2022, SUBJECT RETURNED WITH CONTINUED COMPLAINTS OF PAIN, ESPECIALLY AROUND THE PECTORALIS INSERTION AND TO A LESSER DEGREE IN THE BACK OF THE SHOULDER. HE COMPLAINED OF SOME MECHANICAL SYMPTOMS ESPECIALLY AT NIGHTTIME, WHEN HE IS POSITIONED IN BED, AND WITH MOTION. INFLAMMATORY LAB WORKUP WAS NEGATIVE. DR. (B)(6) SUGGESTED CT SCAN TO RULE OUT MECHANICAL COMPLICATIONS. ON (B)(6) 2022, SUBJECT RETURNED FOR CT REVIEW, WHICH DID NOT SHOW ANY MECHANICAL COMPLICATIONS. SURGEON STATED THAT

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 21122539 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6) SHOUT - TORNIER SHOULDER OUTCOMES STUDY. PAIN IN THE SHOULDER DUE TO A FALL."

  Patient problems: Fall; Implant Pain

  MAUDE report 21045854 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). INFECTION. PATIENT REQUIRED IRRIGATION AND DEBRIDEMENT ALONG WITH ANTIBIOTICS."

  Patient problems: Bacterial Infection

  MAUDE report 20349591 ↗