AETOS Shoulder System GBP-0990-502-15FRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556814390), received between Jan 31, 2024 and Mar 6, 2026 — classified as 2 injuries, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN AETOS TSA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED SIGNS OF INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE 15 DEG AUGMENT BASEPLATE FULL WEDGE WAS EXPLANTED, AND STRYKER IMPLANTS WERE IMPLANTED IN A SINGLE-STAGE REVISION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 24531115 ↗
• InjuryApr 26, 2025Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT, AFTER AN RSA PERFORMED ON (B)(6) 2024, THE PATIENT PRESENTED SHOULDER PAIN. THE SURGEON SUSPECTED THAT ONE OF THE PERIPHERAL SCREWS HAS BROKEN AND THE BASEPLATE MAY BE LOOSE. HE ALSO SUSPECTED THAT THE POLY LINER HAS DISASSOCIATED FROM THE STEM, AS WELL AS A POSSIBLE INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO EXPLANT THE PREVIOUS DEVICES; THE PATIENT WAS TREATED WITH ANTI-BACTERIAL RINSE FOLLOWING THE EXPLANATION. NO OTHER SIGNS OF INFECTION WERE VISUALLY PRESENT, AND THE SURGEON PROCEEDED TO IMPLANT A TORNIER PYROCARBON HEMI CONSTRUCT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection; Pain

  MAUDE report 21915681 ↗
• MalfunctionJan 31, 2024Fracture; Material Deformation; Fracture; Material Deformation

  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. (B)(6) DR. 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. (B)(6) DR. 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 18614323 ↗