AETOS Shoulder System GBP-0990-501-2Recalls & reported problems
Smith & Nephew, Inc. · GLENOID BASEPLATE ECCENTRIC · Class 2 · Implant
All models of AETOS Shoulder System (44)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556808443), received between Oct 16, 2024 and Jul 29, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (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
- Adverse Event Without Identified Device or Use Problem1
- Loss of Osseointegration1
Patient problems
- Aseptic loosening1
- Bone Fracture(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT, AFTER THE AETOS SHOULDER SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED LOOSENING OF THE GLENOID BASEPLATE ECCENTRIC IN THE LEFT SHOULDER. THE EXACT CAUSE IS UNCLEAR; HOWEVER, IT MAY BE RELATED TO AN EARLY POSTOPERATIVE FALL THE PATIENT HAD. THIS ADVERSE EVENT BEGAN ON (B)(6) 2025 AND IT WAS DIAGNOSED BY A CLINICAL STUDY. THIS ADVERSE EVENT WAS TREATED BY MEDICATION THERAPY AND A REVISION REVERSE SHOULDER ARTHROPLASTY WAS CONSIDERED TO STABILIZE THE BASEPLATE, BUT THE EVENT REMAINS UNRESOLVED. IT IS UNKNOWN IF THE REVISION SURGERY HAS BEEN SCHEDULED/PERFORMED. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN. NO ADDITIONAL COMPLICATIONS HAVE BEEN REPORTED.
Patient problems: Aseptic loosening
MAUDE report 22640092 ↗InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DURING A CLINICAL STUDY, AFTER A SHOULDER SURGERY USING AN AETOS SYSTEM PERFORMED ON (B)(6) 2024, THE PATIENT SUFFERED A CORACOID FRACTURE. THIS ISSUE WAS SOLVED WITH PHYSICAL THERAPY. THE PATIENT IS CURRENTLY RECOVERED.
Patient problems: Bone Fracture(s)
MAUDE report 20466640 ↗
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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