AETOS Shoulder System TRL-0990-841-38ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556811696), received between Feb 7, 2025 and Jan 30, 2026 — classified as 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Fracture

  IT WAS REPORTED THAT, DURING A TOTAL SHOULDER REPLACEMENT SURGERY, ONE (1) LINER TRIAL ARTICULAR 38MM BROKE WHEN THE SURGEON PLACED A BONE HOOK THROUGH THE TRIAL. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225149 ↗
• MalfunctionFeb 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING REVERSE TOTAL SHOULDER REPLACEMENT SURGERY, ONE (1) LINER TRIAL ARTICULAR 38MM BROKE OFF INTO THE META COMPACTOR STEM TRIAL. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339999 ↗