AETOS Shoulder System SCW-0990-507-40Recalls & reported problems
Smith & Nephew, Inc. · 4.5MM CENTER SCREW 40MM · Class 2 · Implant
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 00885556813607), received between Jan 31, 2024 and Jan 31, 2024 — 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
- Material Twisted/Bent1
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.
MalfunctionJan 31, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN AETOS REVERSE TOTAL SHOULDER, THE HEAD OF THE 4.5MM CENTER SCREW 40MM BROKE WHILE TRYING TO ADVANCE THE SCREW, LEAVING IT TOO PROUD TO ENGAGE THE GLENOSPHERE SET SCREW. DR. MILLER MADE THE DECISION TO REMOVE THE 15 DEG AUGMENT BASEPLATE FULL WEDGE AND IN THE PROCESS OF REMOVING IT, THE THREADS OF THE BASEPLATE INSERTER BROKE OFF IN THE CENTER POST OF THE BASEPLATE. THE THREAD INSIDE THE BASEPLATE THAT GUIDES AND CAPTURES THE CENTER SCREW ALSO BROKE FROM INSIDE THE POST, LEAVING THE CENTER SCREW (WITHOUT THE SCREW HEAD) WITH THE CAPTURE THREAD STILL INSIDE THE VAULT OF THE GLENOID. DR. MILLER ENGAGED THE INSERTER ONTO THE BASEPLATE AND TRIED BACKSLAPPING THE INSERTER HANDLE AND WIGGLING THE HANDLE/BASEPLATE TO DISENGAGE THE BASEPLATE FROM THE NATIVE GLENOID. AFTER ALSO USING AN OSTEOTOME TO TRY TO LEVER THE BASEPLATE OFF THE GLENOID, HE WAS STUCK WITH THE BASEPLATE MAY A FEW MILLIMETERS OFF THE GLENOID. THINKING THE CENTER SCREW WAS HOLDING HIM UP, HE TRIED TO SPIN THE BASEPLATE COUNTERCLOCKWISE TO TRY TO UNSCREW THE BASEPLATE OFF THE CENTER SCREW. AFTER GOING BACK AND FORTH FOR A LONG TIME, THE SCREW THREADS OF THE MACHINED, BASEPLATE & GLENOSPHERE IN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18614114 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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