Titan Modular Shoulder System 2.5 SZR-0926-030-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556862339), received between Apr 6, 2023 and Jul 11, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT DURING TOTAL SHOULDER ARTHROPLASTY SURGERY, THE ATTACHMENT POINT OF ONE (X1) FIN-LOCK SIZER. M AND ONE (X1) FIN-LOCK STEPPED SIZER. M+3 BROKE. THE SCRUB TECH HAD TIGHTENED THE FITTING BETWEEN THE TWO BECAUSE THE SIZE KEPT FALLING OFF. ONCE THE SURGEON TRIED TO PLACE THE FIN-LOCK SIZER. M INSIDE THE SHOULDER, IT BROKE AT THAT ATTACHMENT POINT. IT BROKE IN TO TWO PIECES, THE MAIN BODY OF THE SIZER WHICH WAS EXTRACTED BY THE SURGEON AND THE ATTACHMENT POINT WAS RETAINED IN THE INSERTION HANDLE. WHEN THE FIRST SIZER BROKE, THEY TRIED WITH A FIN-LOCK STEPPED SIZER. M+3 AND EXPERIENCED THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT 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 17302353 ↗
• MalfunctionApr 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TSA SURGERY, THE TIP OF ONE (1) FIN-LOCK SIZER. M BROKE OFF WHILE IN USE. 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 16690381 ↗