AETOS Shoulder System GBP-0990-502-10FRecalls & reported problems
Smith & Nephew, Inc. · 10 DEG AUGMENT BASEPLATE FULL WEDGE · Class 2 · Implant
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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556814383), received between Jul 29, 2024 and Apr 24, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Nonstandard Device” (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 Problem2
- Nonstandard Device1
- Positioning Failure1
Patient problems
- Bacterial Infection1
- Perforation1
- Periprosthetic fracture1
- Post Operative Wound Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Positioning Failure; Nonstandard Device
IT WAS REPORTED THAT, DURING A RTSA SURGERY, WHEN IMPLANTING A GLENOID BASEPLATE 10 DEG FW AUG, THE CENTRAL, SUPERIOR, ANTERIOR AND POSTERIOR PERIPHERAL SCREWS LOCKED WELL, BUT THE INFERIOR SCREW DID NOT LOCK. THE SURGEON TRIED TO DRILL MULTIPLE TIMES AND ALSO TRIED MULTIPLE SCREWS, BUT STILL WOULD NOT LOCK. IT SEEMS LIKE THE BASEPLATE HAS FAULTY THREADS ON THE INFERIOR HOLE. SURGERY WAS RESUMED WITH THE SAME S+N PRODUCT, AND LEAVING THE INFERIOR BASEPLATE HOLE AND BONE HOLE OPEN, WITHOUT ANY SCREW. IT WAS COMPLETED WITH ONLY THREE PERIPHERICAL SCREWS AND ONE CENTRAL SCREW. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY, BUT NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Perforation
MAUDE report 24988526 ↗InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER A SHOULDER REPLACEMENT SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A PERIPROSTHETIC RIGHT SCAPULAR FRACTURE. THIS ADVERSE EVENT WAS TREATED BY REST AND RETURN TO SLING; HOWEVER, THE OUTCOME IS NOT RECOVERED/NOT RESOLVED. THE CURRENT HEALTH STATUS OF THE PATIENT REMAINS UNKNOWN.
Patient problems: Periprosthetic fracture
MAUDE report 22552871 ↗InjuryJul 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A RIGHT TOTAL SHOULDER ARTHROPLASTY SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED POST OPERATIVE WOUND INFECTION/EXCESSIVE POSTOPERATIVE WOUND DRAINAGE. THIS ADVERSE EVENT WAS TREATED BY IRRIGATION AND DEBRIDEMENT OF THE JOINT ON (B)(6) 2024, IN WHICH. PATIENT IS CURRENTLY RECOVERING.
Patient problems: Bacterial Infection; Post Operative Wound Infection
MAUDE report 19857575 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page