NA 75100844Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07611996121773), received between Mar 7, 2021 and Apr 5, 2026 — classified as 6 malfunctions.

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

• MalfunctionApr 5, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE HIP WAS TOO TIGHT AND, WHEN AN ATTEMPT TO REDUCE IT WAS MADE, ONE (1) TRIAL FEMORAL HEAD 28 S/+0 BROKE WHILE TRYING TO REMOVE IT. THE PROCEDURE WAS RESUMED, 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 24786977 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TRIAL FEMORAL HEAD 28 S/+0 BROKE WHILE TRIALING. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED OR IF THIS CAUSED A SURGICAL DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19183307 ↗
• MalfunctionFeb 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INTERNAL FLAP OF THE TRIAL FEMORAL HEAD 28 S/+0 DEVICE THAT SNAPS ONTO STEM, WAS FOUND TO BE FRACTURED. NO PIECES FELL INTO 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 16302049 ↗
• MalfunctionJun 2, 2022Break; Break

  IT WAS REPORTED THAT THE TRIAL FEMORAL HEAD 28 S/+0 BROKE. AS THIS WAS NOTICED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580891 ↗
• MalfunctionJul 21, 2021Crack; Crack

  IT WAS REPORTED THAT A TRIAL FEMORAL HEAD 28 S/+0 HAS A CRACK ON TOP OF THE HEAD TRIAL. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203036 ↗
• MalfunctionMar 7, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A EFIP INSPECTION, THE TRIAL FEMORAL HEAD 28 S/+0 WAS FOUND WITH A FLAP BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429684 ↗