Tornier Flex Shoulder System DWH139Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700434019643), received between Oct 22, 2023 and Mar 5, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, THE PATIENT HAD REVISION SURGERY OF REVIVE STEM WITH PYROCARBON HEAD. IT WAS A CONVERSION TO REVERSE AFTER RECURRENT DISLOCATIONS. ITEMS WERE INTACT AND REMOVED SAFELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Subluxation

  MAUDE report 24521622 ↗
• MalfunctionJan 8, 2026Fracture; Off-Label Use

  IT WAS REPORTED THAT, PYROCARBON HEAD CHIPPED BY SURGEON DURING REMOVAL OF OSTEOPHYTES AROUND THE IMPLANT. IMPLANT WAS FULLY INTACT PRIOR TO ATTEMPTING REMOVAL. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24005278 ↗
• MalfunctionOct 22, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE IMPLANT WAS FOUND BROKEN WHEN THE BOX WAS OPENED. THE LOW OFFSET VERSION OF THE SAME DIAMETER AND HEIGHT WITH NO NOTED COMPROMISE TO THE FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17982331 ↗