AETOS Shoulder System IMP-0990-835Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556811870), received between Aug 31, 2023 and May 31, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A REVERSE SURGERY, THE PLASTIC TIP OF ONE (1) HUMERAL HEAD GLENOSPHERE IMPACTOR BROKE IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25343550 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT, DURING A NAIL SURGERY, THE HUMERAL HEAD GLENOSPHERE IMPACTOR BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646822 ↗
• MalfunctionMar 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN AETOS SHOULDER SYSTEM PROCEDURE, THE TIP OF ONE (1) HUMERAL HEAD GLENOSPHERE IMPACTOR BROKE. THE TIP DID NOT FALL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988069 ↗
• MalfunctionOct 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING HUMERAL SURGERY, AFTER IMPACTION OF THE REVERSE OF ONE (1) HUMERAL HEAD GLENOSPHERE IMPACTOR, IT WAS NOTICED THAT THE TIP OF THE IMPACTOR BROKE OFF. IMPACTION WAS COMPLETED AND NO FURTHER IMPACTOR WAS NEEDED. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17954510 ↗
• MalfunctionSep 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY THE HUMERAL HEAD GLENOSPHERE IMPACTOR BROKE IN THE FINAL IMPACT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683527 ↗
• MalfunctionAug 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TOTAL SHOULDER ARTHROPLASTY, WHILE IMPACTING THE GLENOSPHERE THE BLACK TIP OF A MACHINED, HUMERAL HEAD/GLENOSPHERE IMPACTOR BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663759 ↗
• MalfunctionAug 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TOTAL SHOULDER ARTHROPLASTY PROCEDURE, WHILE IMPACTING THE GLENOSPHERE ONE (1) MACHINED, HUMERAL HEAD/GLENOSPHERE IMPACTOR BROKE. NO PLASTIC PIECES WERE IN THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663510 ↗