AETOS Shoulder System TRL-0990-844-03HRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556812877), received between Feb 27, 2024 and Jan 22, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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.

• MalfunctionJan 22, 2026Crack; Fracture

  IT WAS REPORTED THAT, DURING A REVERSE SHOULDER ARTHROPLASTY SURGERY, A LINER TRIAL HEIGHT +3MM BROKE DURING REDUCTION. THE ISSUE WAS PHYSICAL, ALL PARTS WERE ACCOUNTED FOR AND RETRIEVED OUT OF THE PATIENT BY HAND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152912 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER PROCEDURE, THE SCREW OF THE LINER TRIAL HEIGHT +3 MM THAT THREADS INTO STEM TRIAL WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306726 ↗
• MalfunctionSep 12, 2025Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT, DURING A REVERSE TSA SURGERY, THE SCREW OF THE LINER TRIAL HEIGHT +3MM BROKE AND GOT STUCK IN THE STEM COMPACTOR SIZE 1. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043541 ↗
• MalfunctionMay 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A RTSA SURGERY, THE PLASTIC THAT WRAPS AROUND THE SCREW TIP OF TWO (2) LINER TRIAL HEIGHT +3MM FRACTURED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY; IT IS ALSO UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045853 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY WHEN THE SURGEON WAS SCREWING ONE (1) LINER TRIAL HEIGHT +3MM BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900949 ↗
• MalfunctionSep 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING REVERSE SHOULDER ARTHROPLASTY SURGERY, ONE (1) LINER TRIAL HEIGHT +3MM HAD THE THREADS SNAPPED ON TRAILING. ALL PIECES WERE REMOVED, NONE OF THEM WERE LEFT IN THE BODY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136488 ↗
• MalfunctionFeb 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE TRIALING PORTION OF THE REVERSE SHOULDER, AFTER THE SURGEON DISLOCATED THE ARM, HE WAS STRUGGLING WITH THE REMOVAL OF THE TRIAL. HE WAS TRIALING OF THE META STEM COMPACTOR TRIAL. THIS IS WHEN HE DISCOVERED THAT ONE (1) LINER TRIAL HEIGHT +3MM WAS BROKEN. HE REMOVED THE BROKEN PART AND UNTHREADED THE REMAINING PORTION OF THE TRIAL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18791581 ↗