AETOS Shoulder System COM-0990-808-03Recalls & reported problems
Smith & Nephew, Inc. · STEM COMPACTOR SIZE 3 · Class 1
All models of AETOS Shoulder System (44)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556811948), received between Feb 18, 2025 and Feb 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2025Fracture; Separation Failure; Fracture; Separation Failure
IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, AFTER PUTTING ONE (1) TRIAL STEM COMPACTOR SIZE 3 INTO THE HUMERUS, THE DOCTOR SCREWED THE 38, +0 LINER TRIAL INTO THE STEM, AND WHEN TRYING TO DISENGAGE THE LINER TRIAL THE THREADS WERE STUCK IN THE TRIAL STEM. THE THREADS OF THE LINER TRIAL BROKE OFF AND STUCK INTO THE TRIAL STEM. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21397809 ↗
Other BROACH devices
- NA 2598-07-550Depuy (Ireland) · BROACH323 reports
- SUMMIT 2570-00-000Depuy (Ireland) · BROACH269 reports
- NA 952212500FDepuy (Ireland) · BROACH245 reports
- ACTIS 2010-01-050Depuy (Ireland) · BROACH235 reports
- CORAIL 9522-11-500Depuy (Ireland) · BROACH210 reports
- ACTIS 2010-01-060Depuy (Ireland) · BROACH186 reports
- ACTIS 2010-01-040Depuy (Ireland) · BROACH172 reports
- ACTIS 2010-01-070Depuy (Ireland) · BROACH162 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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