Titan Modular Shoulder System INS-0923-046-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556860779), received between Jun 12, 2023 and Jun 12, 2023 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 17113623 ↗