AETOS Shoulder System TRL-0990-844-00HRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00885556812860), received between Nov 3, 2023 and Jun 12, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Fracture” (32 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE (1) LINER TRIAL HEIGHT +0MM WAS BROKE DURING REDUCTION. 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 25494358 ↗
• MalfunctionJun 1, 2026Fracture

  IT WAS REPORTED THAT, DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY SURGERY, THE SCREW OF ONE (1) LINER TRIAL HEIGHT +0MM SPLIT IN HALF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347435 ↗
• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A AETOS SHOULDER SURGERY, THE SCREW PEG OF ONE (1) LINER TRIAL HEIGHT +0MM BROKE OFF AFTER TIGHTENING DOWN THE LINER HEIGHT TRIAL. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25342814 ↗
• MalfunctionApr 28, 2026Fracture

  IT WAS REPORTED THAT, DURING A SHOULDER PROCEDURE, THE LINER TRIAL HEIGHT +0MM BROKE AT THE POST DURING SURGERY. THE ITEM DID NOT FRAGMENT, AND ALL PARTS WERE ACCOUNTED FOR. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED. CURRENT HEALTH OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017120 ↗
• MalfunctionApr 15, 2026Fracture

  IT WAS REPORTED THAT, DURING A TSA SURGERY, THE PLASTIC ON ONE (1) LINER TRIAL HEIGHT +0MM AND ONE (1) LINER TRIAL ARTICULAR 34MM BROKE. THE PROCEDURE WAS PERFORMED, 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 24889399 ↗
• MalfunctionMar 11, 2026Fracture

  IT WAS REPORTED THAT DURING A TSA, THE LINER TRIAL HEIGHT +0 MM BROKE INSIDE THE STEM WHEN REDUCING. NO PIECES LEFT INSIDE THE PATIENT; THEY WERE RECOVERED BY HAND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568569 ↗
• MalfunctionMar 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A REVERSE SHOULDER ARTHROPLASTY, TWO (2) LINER TRIAL HEIGHT +0MM BROKE DURING REDUCTION NO PIECES FROM THE DEVICE WERE LEFT IN THE PATIENT. 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 24483044 ↗
• MalfunctionFeb 21, 2026Fracture

  IT WAS REPORTED THAT, DURING AN AETOS SHOULDER SURGERY, AFTER TRIALING GLENOID, THE SCREW THAT TIGHTNESS DOWN THE LINER TRIAL HEIGHT +0 MM, SNAPPED OFF. NOTHING FELL INTO PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410421 ↗
• MalfunctionFeb 18, 2026Fracture

  IT WAS REPORTED THAT, DURING AN AETOS SHOULDER SURGERY, AFTER TIGHTENING THE GLENOID, THE SCREW OF THE LINER TRIAL HEIGHT +0MM, BROKE OFF. NOTHING FELL INTO PATIENT. IT IS UNKNOWN HOW PROCEDURE WAS FINISHED AND IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383440 ↗
• MalfunctionFeb 9, 2026Fracture

  IT WAS REPORTED THAT, DURING A TSA SURGERY ONE (1) LINER TRIAL HEIGHT +0MM SNAPPED WHEN DISLOCATING THE HUMERUS. ALL THE BROKEN PIECES WERE REMOVED BY HAND. NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298902 ↗
• MalfunctionFeb 8, 2026Crack; Fracture

  IT WAS REPORTED THAT, DURING AN RSA SURGERY ONE (1) LINER TRIAL HEIGHT +0MM SNAPPED VERTICALLY ALONG THE SIDE OF THE STEM WHEN HAND TIGHTENING INTO THE HUMERAL STEM TRIAL. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288386 ↗
• MalfunctionJan 27, 2026Fracture

  IT WAS REPORTED THAT, DURING A RSA SURGERY, ONE (1) LINER TRIAL HEIGHT +0MM SCREW BROKE OFF AFTER TIGHTENING. NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192731 ↗
• MalfunctionDec 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A AETOS SHOULDER SURGERY, AFTER TIGHTENING THE SCREW ON ONE (1) LINER TRIAL HEIGHT +0MM, THE CENTER POST SNAPPED OFF. ALL PIECES RETRIEVED BY HAND AND NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING THE SAME S+N PRODUCT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782967 ↗
• MalfunctionNov 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY, THE LINER TRIAL HEIGHT +0MM BROKE IN HALF DURING REDUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577143 ↗
• MalfunctionNov 6, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING A REVERSE SHOULDER ARTHROPLASTY, ONE (1) LINER TRIAL HEIGHT +0MM BROKE DURING REDUCTION NO PIECES FROM THE DEVICE WERE LEFT IN THE PATIENT. 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 23493170 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A TSA SURGERY, ONE (1) LINER TRIAL HEIGHT +0MM BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410916 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN RSA SURGERY, IT WAS NOTICED THAT THE LINER TRIAL HEIGHT +0MM WAS BROKEN WHEN THE SHOULDER WAS PUT BACK INTO PLACE. THE PIECE WAS BROKEN IN TWO PIECES, BOTH RETRIEVED BY HAND. NOTHING WAS LEFT IN THE PATIENT. 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 23366594 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL REVERSE SHOULDER ARTHROPLASTY SURGERY THE SCREW OF ONE (1) LINER TRIAL HEIGHT +0MM BROKE OFF. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING AN EQUIVALENT S+N BACKUP DEVICE. NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364280 ↗
• MalfunctionOct 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TSA SURGERY, THE STEM OF A LINER TRIAL HEIGHT +0MM SNAPPED OFF AT SOME POINT DURING SURGERY. THE DEVICE BROKE WHILE INSERTING THE PART INSIDE THE PATIENT. NO PIECES FELL INTO THE WOUND. ALL THE BROKEN PIECES WERE ACCOUNTED FOR, BY HAND. NO X RAYS ARE AVAILABLE. 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 23216090 ↗
• MalfunctionSep 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING REVERSE SHOULDER ARTHROPLASTY, SURGEON FRACTURED ONE (1) LINER TRIAL HEIGHT +0MM WHILE TRIALING. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026331 ↗
• MalfunctionAug 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REVERSE SHOULDER ARTHROPLASTY, THE CENTER OF ONE (1) LINER TRIAL HEIGHT +0 MM SNAPPED OFF INTO TWO PIECES WHILE INSERTING THE TRIAL INTO THE TRIAL STEM. THE TWO PIECES WERE REMOVED IMMEDIATELY WITH A HEMOSTAT; NO FRAGMENTS WERE LEFT IN THE PATIENT. 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 22900973 ↗
• MalfunctionJul 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A RSA SURGERY, THE SURGEON TIGHTENED THE TRIAL FINGER TIGHT OF ONE (1) LINER TRIAL HEIGHT +0MM TO A POINT THAT CAUSED THE POST OF THE TRIAL TO SNAP OFF. THE SURGICAL SITE WAS IRRIGATED TO ENSURE NO PIECES WERE LEFT BEHIND. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22465427 ↗
• MalfunctionMay 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TSA SURGERY, ONE (1) LINER TRIAL HEIGHT +0MM SNAPPED WHILE INSERTING. THE BREAK OCCURRED OUTSIDE THE PATIENT AND WAS A CLEAN, NON-SHATTERING FRACTURE, RESULTING IN TWO SEPARATE PIECES. BOTH FRAGMENTS WERE ACCOUNTED FOR AND PROPERLY DISPOSED OF. 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 21999362 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROPLASTY, ONE (1) LINER TRIAL HEIGHT +0MM WAS BROKEN. IT GOT STUCK WHEN SCREWED INTO THE HUMERAL TRIAL AND BROKE WHEN TRIED TO REMOVE IT. 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 21990922 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER REPLACEMENT, THE THREADS ON THE LINER TRIAL HEIGHT +0MM BROKE OFF. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 21715508 ↗