NA 75100871Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07611996122046), received between Dec 28, 2020 and Dec 26, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE THA SURGERY, THE TABS OF THE TRIAL FEMORAL HEAD 40 L/+8 BROKE OFF THE BASE OF THE HEAD, WHEN THE HEAD TRIAL WAS BEING CONNECTED TO THE STEM. THE PROCEDURE WAS PERFORMED, 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 23898003 ↗
• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED THAT, DURING A THR THE INNER LOCKING MECHANISM OF A TRIAL FEMORAL HEAD 40 L/+8 WAS BROKEN AND IT WOULD NOT SNAP ONTO THE STEM. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE AND NO PIECES FELT INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17978067 ↗
• MalfunctionSep 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE INNER PLASTIC LOCKING PIECES OF ONE (1) TRIAL FEMORAL HEAD 40 L/+8 FRACTURED AFTER REMOVING FROM STEM. 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 17782671 ↗
• MalfunctionDec 28, 2020Fracture; Fracture

  IT WAS REPORTED THAT, WHILE RESETTING INSTRUMENTS, IT WAS NOTICED THAT THE TRIAL FEMORAL HEAD WAS BROKEN. NO CASE OR PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085385 ↗