Titan Modular Shoulder System 2.5 ROD-0923-040-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556861912), received between Jun 12, 2023 and Jun 1, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Fracture

  IT WAS REPORTED THAT, DURING A RTSA SURGERY, THE THREADS OF ONE (1) TSS HEAD CUTTING TEMPLATE ROD. 2.5 BROKE OFF INTO THE INSERTER DURING IMPACTING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354361 ↗
• MalfunctionApr 22, 2026Fracture

  IT WAS REPORTED THAT, DURING A RTSA, WHEN TRYING TO MALLET BROACH HANDLE OUT, ONE (1) TSS HEAD CUTTING TEMPLATE ROD. 2.5 WAS STRUCK AND THREADS BROKE. 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 24953458 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL REVERSE REVISION SHOULDER ONE (1) TSS HEAD CUTTING TEMPLATE ROD. 2.5 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 22067376 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, TWO (2) TSS HEAD CUTTING TEMPLATE ROD. 2.5 BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170963 ↗
• MalfunctionJan 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TSA SURGERY, ONE (1) TSS HEAD CUTTING TEMPLATE ROD. 2.5; ONE (1) RSS HUMERAL BODY INSERTER / EXTRACTOR AND ONE (1) COMBO INSERTER/IMPACTOR. M WERE BROKE DURING THE CASE. NO X-RAYS AVAILABLE, ITEMS WERE NOT BROKEN INSIDE PATIENT AND NO PIECES WERE LEFT IN PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490763 ↗
• MalfunctionSep 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING REVERSE TOTAL SHOULDER SURGERY, THE (X1) TSS HEAD CUTTING TEMPLATE ROD. 2.5 BROKE OFF INTO THE (X1) RSS HUMERAL BODY INSERTER / EXTRACTOR, AND THE (X1) RSS GLENOID BASEPLATE IMPACTOR-S WILL NOT HOLD THE BASEPLATE IMPLANT FIRMLY. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675041 ↗
• MalfunctionJul 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SHOULDER REPLACEMENT SURGERY, WHILE SCREWING INTO THE TRIAL HANDLE, THE TREADS OF THE TSS HEAD CUTTING TEMPLATE ROD. 2.5 DEVICE SNAPPED INSIDE THE HANDLE. THE PIECE WAS RETRIEVED OUT OF THE HANDLE. 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 17393313 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT DURING A PRIMARY TOTAL SHOULDER ARTHROPLASTY THE TSS HEAD CUTTING TEMPLATE ROD. 2.5 WAS INADVERTENTLY BROKEN OFF IN THE HANDLE BY A SLIPPED SWING OF THE MALLET, CAUSING THE THREADS OF THE TSS TRIAL INSERTER/EXTRACTOR. 2.5 TO BREAK OFF. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED AND NO PIECES FELL INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113626 ↗