Titan Reverse Shoulder System INS-0960-094-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00885556863992), received between Mar 29, 2023 and May 31, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Fracture” (17 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A REVERSE TSA SURGERY, THE THREAD OF ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE OFF WHILE IMPLANTING THE STEM. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344330 ↗
• MalfunctionApr 30, 2026Fracture

  IT WAS REPORTED THAT, DURING AETOS SHOULDER SURGERY, WHILE REMOVING THE TRIAL FROM THE PATIENT, THE THREADS OF THE RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE OFF. 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 25045662 ↗
• MalfunctionFeb 4, 2026Fracture; Separation Failure

  IT WAS REPORTED THAT, DURING A TITAN SHOULDER SURGERY, ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE OFF INSIDE ONE (1) RSS HUMERAL BODY INSERTER / EXTRACTOR AND ONE (1) REAMER GUIDE BODY INSERTER/ EXTRACTOR MOD. THE BODY COULD NOT BE SEPARATED FROM THE INSERTER. NOTHING FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259957 ↗
• MalfunctionFeb 3, 2026Fracture

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB 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 24246084 ↗
• MalfunctionDec 5, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A TSA SURGERY, A RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730407 ↗
• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TSA SURGERY, TWO (2) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS NO DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23262660 ↗
• MalfunctionSep 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING RSA SURGERY ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE TRYING TO REMOVE THE IMPLANT. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE OR DELAY. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935675 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT, DURING A REVERSE SHOULDER SURGERY, TWO (2) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB WERE BROKEN. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF THERE WAS SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804527 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT, DURING A REVERSE SHOULDER SURGERY, ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB WAS BROKEN. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF THERE WAS SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804523 ↗
• MalfunctionAug 4, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TSA SURGERY, THE SCREW OF ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE. 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 22709208 ↗
• MalfunctionMay 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TSA SURGERY, ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE IN HALF. ALL PIECES WERE RECOVERED FROM THE PATIENT. 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 22101495 ↗
• MalfunctionApr 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TSA, THE WING NUT OF ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE DURING IMPLANT INSERTION. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. 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 21912895 ↗
• MalfunctionApr 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER SURGERY, AT THE TRIALING PHASE, THE T-KNOB OF ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB WAS BEING REATTACHED TO THE TRIAL AND THE THREADED PORTION SHEARED APART, LEAVING THE DISTAL PORTION OF THE THREADS ATTACHED TO THE SMALL BODY HUMERAL TRIAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY BY CHANGING THE SURGICAL PROCEDURE, USING A SCREW IN T HANDLE TO INSERT THE PERMANENT IMPLANT AS OPPOSED TO USING THE ACTUAL IMPLANT INSERTER. NO PIECES FELL, OR WERE FOUND, INSIDE OF THE PATIENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912738 ↗
• MalfunctionDec 29, 2024Break; Break

  IT WAS REPORTED THAT, DURING A REVISION TSA SURGERY, ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND IF THERE WAS SURGICAL DELAY. NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032130 ↗
• MalfunctionApr 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TITAN REVERSE SHOULDER SURGERY, ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB SHEARED OFF BELOW THE KNOB, THE PART THAT SCREWS IN. NOTHING FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, IT IS UNKNOWN HOW. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19142627 ↗
• MalfunctionApr 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER REPLACEMENT SURGERY, A RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19097642 ↗
• MalfunctionApr 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER REPLACEMENT SURGERY, THE KNOB OF THE RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19088637 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING REMOVAL OF TRIAL CONSTRUCT IN A TITAN REVERSE SHOULDER, THE RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE LEAVING THE CONSTRUCT STUCK ON THE INSERTER HANDLE. THE WOUND WAS IRRIGATED TO ENSURE NO PIECES WERE LEFT IN THE JOINT. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY (LESS THAN OR EQUAL TO 30MINS) 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 18840382 ↗
• MalfunctionMar 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A RSA PROCEDURE, THE THREADS ON A RSS HUMERAL BODY INSERTER EXTRACTOR KNOB BROKE OFF. 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 18831168 ↗
• MalfunctionJan 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, ONE RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE OFF INTO THE IMPLANT, BUT THEY WERE ABLE TO REMOVED IT AND UNTHREAD IT FROM THE IMPLANT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS ANY DELAY. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530785 ↗
• MalfunctionNov 28, 2023Break; Break

  IT WAS REPORTED THAT, DURING CASE, ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE AND IT WAS MISTAKENLY THROWN AWAY AFTER THE CASE. IT IS UNKNOWN IF THERE WAS A DELAY AND HOW THE PROBLEM WAS SOLVED. PATIENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18217949 ↗
• MalfunctionOct 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TSA, (2) TWO RSS HUMERAL BODY INSERTER/EXTRACTOR KNOB BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994827 ↗
• MalfunctionOct 16, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE KNOB OF A HUMERAL BODY INSERTER/EXTRACTOR BROKE AT INSERTION POINT. NO PIECES FELL INTO PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940935 ↗
• MalfunctionMar 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TSR SURGERY, THE RSS HUMERAL BODY INSERTER EXTRACTOR KNOB BROKE OFF IN THE REAMER GUIDE BODY INSERTER EXTRACTOR MOD. THE INSERTER WAS STUCK ON THE TRIAL BODY AND WAS ABLE TO BE REMOVED FROM THE PATIENT AS ONE PIECE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACKUP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635224 ↗