NA 75100869Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07611996122022), received between Feb 14, 2021 and Mar 1, 2024 — classified as 7 malfunctions.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, THE INNER TAB OF A TRIAL FEMORAL HEAD 40 S/+0 FRACTURED OFF. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18820538 ↗
• MalfunctionNov 3, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, IT WAS NOTICED THAT TWO (2) TRIAL FEMORAL HEAD 40 S/+0 WERE BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065115 ↗
• MalfunctionMay 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, ONE (1) TRIAL FEMORAL HEAD 40 S/+0 BROKE ON THE INSIDE. 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 17034933 ↗
• MalfunctionApr 30, 2023Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) TRIAL FEMORAL HEAD 40 S/+0 WAS BROKEN ON THE INSIDE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841524 ↗
• MalfunctionDec 23, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A TRIAL FEMORAL HEAD 40 S/+0 BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078983 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED THAT THE INNER TAB OF THE TRIAL FEMORAL HEAD 40 S/+0 WAS BROKEN. AS NOTICED DURING FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11808875 ↗
• MalfunctionFeb 14, 2021Break; Break

  IT WAS REPORTED THAT UPON EFIP INSPECTION, TABS IN THE TRIAL FEMORAL HEAD 40 S/+0 WERE FOUND BROKEN. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326115 ↗