AETOS Shoulder System INS-0990-830-02Recalls & reported problems
Smith & Nephew, Inc. · GLENOID INSERTER TIP M · Class 2
All models of AETOS Shoulder System (44)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556811016), received between Nov 20, 2024 and Jul 1, 2025 — classified as 3 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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2025Break; Break
IT WAS REPORTED THAT, DURING A SHOULDER REPLACEMENT SURGERY, ONE (1) GLENOID INSERTER TIP M BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED OR IF THERE WAS A SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22373125 ↗MalfunctionMay 14, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE (1) GLENOID INSERTER TIP M BROKE OFF. DURING THE GLENOID IMPLANT IMPLANTATION, THE SURGEON IMPACTED THE GLENOID COMPONENT INTO THE GLENOID AND ONE OF THE FEET ON THE GLENOID INSERTER TIP M BROKE OFF. THE BROKEN FOOT WAS RETRIEVED FROM THE SHOULDER. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO DELAY OR INJURIES REPORTED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22023103 ↗MalfunctionNov 20, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN ANATOMIC TOTAL SHOULDER, THE GLENOID INSERTER TIP M BROKE TWO TINES UPON IMPACTION. ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20733057 ↗
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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