Titan Modular Shoulder System 2.5 IMP-0926-030-01ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556860731), received between Dec 20, 2022 and Dec 11, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TSA SURGERY, ONE (1) COMBO INSERTER/IMPACTOR. S 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 23779579 ↗
• MalfunctionFeb 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY, WHEN INSERTING THE FIN-LOCK INTO THE PATIENT, ONE OF THE ARMS OF THE COMBO INSERTER/IMPACTOR. S DEVICE 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 16383570 ↗
• MalfunctionDec 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, A COMBO INSERTER/IMPACTOR. S BROKE DURING THE INSERTING OF THE IMPLANT. SURGERY WAS FINISHED WITHOUT ANY DELAY WITH THE SAME DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015258 ↗
• MalfunctionDec 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, A FIN-LOCK GLENOID, S, MACHINED BROKE WHILE INSERTING THE IMPLANT. SURGERY WAS FINISHED AFTER A NON-SIGNIFICANT DELAY WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015126 ↗