Titan Modular Shoulder System 2.5 MAL-0920-085-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556861141), received between Feb 23, 2023 and Feb 26, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER, THE PLASTIC PART ON SLOTTED MALLET BROKE WHILE USING. 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 24462652 ↗
• MalfunctionFeb 10, 2026Fracture

  IT WAS REPORTED THAT DURING A REVERSE TOTAL SHOULDER, THE PLASTIC PIECE OF THE SLOTTED MALLET BROKE. 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 24303461 ↗
• MalfunctionDec 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT THE RUBBER END OF ONE (1) SLOTTED MALLET BROKE OFF. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18397461 ↗
• MalfunctionJun 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TSA SURGERY, THE PLASTIC PIECE OF A SLOTTED MALLET BROKE OFF WHILE IMPACTING. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THIS ISSUE CAUSED A DELAY TO PROCEDURE. NO INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17191193 ↗
• MalfunctionApr 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TSA SURGERY, THE PLASTIC PIECE ONE (1) SLOTTED MALLET BROKE AND FLIED OFF WHILE IN USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A COMPETITOR DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690862 ↗
• MalfunctionFeb 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING PROCEDURE, THE WHITE CAP OF THE SLOTTED MALLET BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY BY CHANGING THE SURGICAL TECHNIQUE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16429520 ↗