AETOS Shoulder System GLS0990-506-4200CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556814451), received between Sep 6, 2023 and Oct 23, 2024 — classified as 1 injury, 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A TSA SURGERY, UPON ROUTINE IMPLANTATION OF THE 42MM GLENOSPHERE CONCENTRIC, THE SET SCREW INSIDE OF IT WOULD NOT FULLY ENGAGE WITH THE GLENOID BASEPLATE. UPON FINALLY REMOVING THE IMPLANT, IT WAS DISCOVERED THAT THE SET SCREW ITSELF HAD BROKEN OFF FROM THE DEVICE AND HAD TO BE EXTRACTED SEPARATELY FROM THE BASEPLATE. FURTHERMORE, WHILE TRYING TO EXTRACT THE FAULTY GLENOSPHERE, THE T-20 DRIVER 4.5MM PERIPHERAL SCREWS WERE STARTING TO SHOW SIGNS OF STRIPPING IN THE DRIVER TIP THREADS. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED OR IF THERE WAS ANY DELAY. NO FURTHER CONSEQUENCES WERE REPORTED AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517068 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT AETOS REVERSE TOTAL SHOULDER ARTHROPLASTY DONE WITHOUT COMPLICATION ON (B)(6) 2023, DURING THE FIRST POST-OPERATIVE VISIT, IT WAS DISCOVERED THAT THE PATIENTS LEFT SHOULDER WAS INFECTED. TO TREAT THIS ADVERSE EVENT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 DURING WHICH A 42MM GLENOSPHERE CONCENTRIC AND A 42MM REVERSE LINER +6 L WERE EXPLANTED WITHOUT ISSUE, FOLLOWED BY A THOROUGH IRRIGATION WITH ANTIBIOTICS OF THE INFECTED LEFT SHOULDER. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 17691028 ↗