AETOS Shoulder System LNR-0990-200-386SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556810156), received between Mar 12, 2024 and Jan 7, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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.

• InjuryJan 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER RSA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A DISLOCATION DURING PHYSICAL THERAPY. THE POLY COMPONENT IS BELIEVED TO HAVE DISENGAGED FROM A 9 MM METAL SPACER. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH 38MM REVERSE LINER +6 S WAS REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 23989310 ↗
• InjuryJul 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER AN RSA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A DISLOCATION ABOUT 3.5 MONTHS POST OP, WHERE THE 38MM REVERSE LINER +6 S HAD SEPARATED FROM THE META HUMERAL STEM SIZE 2 S. THIS HAPPENED DURING AN ATRAUMATIC EVENT, WHILE LIFTING AN EMPTY GARBAGE CAN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH IT WAS DETERMINED THAT THE STEM WAS WELL FIXATED CAUSING NO CONCERN, AND THAT THE GLENOID SIDE WAS IN GOOD SHAPE, SO NEITHER DEVICE REQUIRED REVISION. IT WAS OPTED TO EXPLANT THE 38MM REVERSE LINER +6 S, AND A +9 SMALL SPACER AND 38 +0 SMALL LINER WERE IMPLANTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 22493386 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT, AFTER A REVERSE SHOULDER REPLACEMENT WITH AETOS WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED A POLY DISSOCIATION DUE TO A FALL. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE 38MM REVERSE LINER +6 S AND THE 38MM GLENOSPHERE CONCENTRIC WERE EXCHANGED. BOTH IMPLANTS WERE UPSIZED TO 42MM IMPLANTS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 18888386 ↗