Titan Reverse Shoulder System INS-0960-049-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556863978), received between Sep 20, 2023 and Oct 2, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE KNOT OF TWO (2) REAMER GUIDE BODY INSERTER/EXTRACTOR MOD BROKE OFF. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851584 ↗
• MalfunctionSep 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING REVERSE SHOULDER SURGERY, THE JUNCTION TIP OF A REAMER GUIDE BODY INSERTER/EXTRACTOR BROKE OFF. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785119 ↗