AETOS Shoulder System INS-0990-861Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00885556812280), received between Oct 13, 2023 and Jul 14, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Fracture” (35 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25818561 ↗
• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING AN RSA, THE TIP OF ONE (1) BASEPLATE/GLENOSPHERE INSERTER BROKE OFF INSIDE BASEPLATE UPON IMPACTION, NO PIECES LEFT IN 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 25341874 ↗
• MalfunctionMar 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, WHILE USING ONE (1) BASEPLATE/GLENOSPHERE INSERTER FOR GLENOSPHERE IMPLANTATION, THE TIP BROKE OFF INSIDE THE GLENOSPHERE. THE SURGEON PLACED THE GLENOSPHERE ONTO THE MORSE TAPER OF THE BASEPLATE TO PROVISIONALLY ENGAGE AND TAPPED THE INSERTER WITH A MALLET ON-AXIS ONTO THE BASEPLATE, AND THE TIP OF THE INSERTER BROKE OFF INSIDE THE GLENOSPHERE. THEY WERE ABLE TO USE A FREE NEEDLE TO REMOVE THE BROKEN TIP FROM THE GLENOSPHERE AND CONTINUE THE OPERATION. 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 24483699 ↗
• MalfunctionFeb 9, 2026Fracture; Damaged Thread

  IT WAS REPORTED THAT, DURING A TOTAL SHOULDER ARTHROPLASTY SURGERY, ONE (1) BASEPLATE/GLENOSPHERE INSERTER CHIPPED DURING INSERTION. NO PIECES FELL INSIDE 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 24297727 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT DURING A REVERSE TSA SURGERY, THE INNER THREAD OF ONE (1) BASEPLATE/GLENOSPHERE INSERTER BROKE WHILE INSERTING THE GLENOID BASEPLATE. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24196481 ↗
• MalfunctionJan 12, 2026Fracture; Separation Failure

  IT WAS REPORTED THAT DURING AN RTSA SURGERY, ONE (1) BASEPLATE/GLENOSPHERE INSERTER BROKE OFF. THE MOST DISTAL THREADS OF THE INSERTER GOT STUCK IN THE CENTER OF THE BASEPLATE, SO IT WAS REMOVED AND REPLACED WITH A NEW ONE. 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 24035179 ↗
• MalfunctionJan 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A RSA SURGERY, AFTER IMPLANTING ONE (1) 38MM GLENOSPHERE CONCENTRIC THE LOCKING SCREW DID NOT ENGAGE ONE (1) 15 DEG AUGMENT BASEPLATE FULL WEDGE. THE DOCTOR USED ONE (1) BASEPLATE/GLENOSPHERE INSERTER TO RE-IMPLANT THE BASEPLATE, THIS LOOSENED THE GLENOSPHERE AND IT CAME OFF THE BASEPLATE. THE GLENOSPHERE WAS REATTACHED TO THE INSERTER AND IMPACTED. AT SOME POINT DURING THE IMPACTION, THE THREADED PORTION OF THE INSERTER HANDLE SHEARED OFF INTO THE GLENOSPHERE. THE DOCTOR USED A TROCAR TIPPED K-WIRE TO GET THE BROKEN PIECE OUT OF THE GLENOSPHERE. HE THEN USED THE TORQUE LIMITING HANDLE ON THE LOCKING SCREW, AND IT CLICKED FOR THE SURGICAL TECHNIQUE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943652 ↗
• MalfunctionDec 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A RTSA SURGERY, THE BASEPLATE OF ONE (1) BASEPLATE/GLENOSPHERE INSERTER BROKE OFF OF THE INSERTER. 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 23886035 ↗
• MalfunctionNov 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN RTSA THE BASEPLATE/GLENOSPHERE INSERTER TIP BROKE OFF WHILE IMPACTING; IT IS UNKNOWN WHETHER THERE WAS DAMAGE OR FAILURE IN THE GLENOID BASEPLATE CENTERED. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING AN S+N BACKUP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571158 ↗
• MalfunctionNov 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN RTSA THE BASEPLATE/GLENOSPHERE INSERTER TIP BROKE OFF WHILE IMPACTING THE GLENOSPHERE. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING THE SAME DEVICE, AND THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571133 ↗
• MalfunctionNov 15, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE (1) BASEPLATE/GLENOSPHERE INSERTER CHIPPED DURING INSERTION. NO PIECES FELL INSIDE 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 23564235 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REVERSE SHOULDER ARTHROPLASTY, THE TIP OF THE BASEPLATE/GLENOSPHERE INSERTER SNAPPED OFF INSIDE THE BASEPLATE DURING INITIAL IMPACTION. THE PIECES WERE REMOVED WITH TWEEZERS. NO PIECES REMAINED IN PATIENT. 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 23364727 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE THREADED TIP OF ONE (1) BASEPLATE/GLENOSPHERE INSERTER BROKE OFF DURING GLENOSPHERE IMPACTION. THE SURGEON RETRIEVED THE BROKEN TIP, AND THE GLENOSPHERE WAS IMPACTED AND SECURED VIA THE PRELOADED SET SCREW WITHOUT INCIDENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. ALL PARTS WERE RECOVERED, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364298 ↗
• MalfunctionOct 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, WHEN INSERTING THE GLENOID BASEPLATE CENTERED ON THE BASEPLATE INSERTER, THIS INSERTER BROKE OFF OF THE BASEPLATE, AND THE TIP (THREADS) OF THE INSERTER WAS STUCK IN THE BASEPLATE, AND IT WAS UNABLE TO GET IT OUT. NO ADDITIONAL ANESTHESIA WAS NECESSARY. 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 23318528 ↗
• MalfunctionSep 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING REVERSE SHOULDER ARTHROPLASTY, THE THREADED ROD, THAT ATTACHES THE BASEPLATE/GLENOSPHERE INSERTER TO THE BASEPLATE, FRACTURED THE END OFF AFTER BEING REATTACHED TO THE BASEPLATE IN-SITU. 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 23026363 ↗
• MalfunctionAug 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TS SURGERY, THE THREADED TIP OF ONE (1) BASEPLATE/GLENOSPHERE INSERTER BROKE OFF DURING GLENOSPHERE IMPACTION. SURGEON RETRIEVED THE TIP WITH HIS FINGERS. GLENOSHPERE IMPACTED AND SECURED VIA PRELOADED SET SCREW WITHOUT INCIDENT. ALL PARTS RECOVERED. 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 22883815 ↗
• MalfunctionJun 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A RSA SURGERY, THE THREADS OF ONE (1) BASEPLATE/GLENOSPHERE INSERTER WERE NOT CAPTURED CORRECTLY AND BROKE OFF INTO ONE (1) 38MM GLENOSPHERE, CONCENTRIC. 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 22292894 ↗
• MalfunctionMar 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING REVERSE TOTAL SHOULDER REPLACEMENT SURGERY, WHEN IMPACTING BASEPLATE, ONE (1) BASEPLATE/GLENOSPHERE INSERTER BROKE. THE THREADS BROKE OFF. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION, HOW WAS THE PROCEDURE COMPLETED, OR IF IT CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566572 ↗
• MalfunctionFeb 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A RTSA, THE THREADS OF A BASEPLATE/GLENOSPHERE INSERTER BROKE WHILE IMPACTING. AT THIS TIME, IT IS UNKNOWN IF ANY PIECES FELL INTO PATIENT. THERE WAS A DELAY GREATER THAN 30 MINUTES, BUT IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469218 ↗
• MalfunctionAug 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY, WHILE ATTEMPTING TO IMPACT A GLENOSPHERE USING A BASEPLATE/GLENOSPHERE INSERTER, THE THREADED ROD SHEARED OFF. THE SURGEON REMOVED THE RETAINED THREADS FROM THE GLENOSPHERE. THE PROCEDURE 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 19950821 ↗
• MalfunctionMay 2, 2024Break; Break

  IT WAS REPORTED THAT, DURING TOTAL SHOULDER ARTHROPLASTY SURGERY, THE THREADED PIECE OF A BASEPLATE/GLENOSPHERE INSERTER BROKE IN THE GLENOSPHERE. 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 19232546 ↗
• MalfunctionApr 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, ONE (1) BASEPLATE GLENOSPHERE INSERTER WAS NOTICED TO BE BROKEN WHILE INSERTING A BASEPLATE. THE THREADED PORTION OF THE INSERTER BROKE OFF INSIDE THE BASEPLATE AFTER IMPACTION. THE BROKEN PORTION OF THE INSERTER WAS ABLE TO BE EXTRACTED OUT OF THE BASEPLATE. NO PIECES FELL INSIDE PATIENT. 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 19081697 ↗
• MalfunctionApr 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF ONE (1) BASEPLATE GLENOSPHERE INSERTER BROKE OFF IN THE BASEPLATE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAYED. NO PATIENT INJURIES WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061298 ↗
• MalfunctionMar 26, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN RSA PROCEDURE, ONE (1) BASEPLATE/GLENOSPHERE INSERTER BROKE INSIDE A 10 DEG FULL WEDGE BASEPLATE. THE SCREW THREAD BROKE OFF INSIDE THE BASEPLATE. THE PROCEDURE WAS RESUMED USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983890 ↗
• MalfunctionMar 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN RSA PROCEDURE, A BASEPLATE GLENOSPHERE INSERTER BROKEN ON IMPACTION OF BASEPLATE. 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 18983878 ↗