NA 75100852Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07611996121858), received between Dec 22, 2020 and Jun 16, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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.

• MalfunctionJun 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT ONE TRIAL FEMORAL HEAD 32 L/+8 IS FRACTURED AND WON'T SECURE TO NECK TRIAL. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14711049 ↗
• MalfunctionMay 11, 2022Break; Break

  IT WAS REPORTED THAT, TWO (2 )TRIAL FEMORAL HEAD 32 +8 WERE FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14359275 ↗
• InjuryMay 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT 5 TRIAL HEADS HAD AN UNSPECIFIED FAILURE. UPON ARRIVAL, IT WAS NOTICED THAT ALL OF THEM HAD A BROKEN FIN. IT IS UNKNOWN WHEN THE FAILURE OCCURRED AND IF THERE WAS ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838254 ↗
• MalfunctionDec 22, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THREE TRIAL FEMORAL HEAD 32 L/+8 WERE FOUND BROKEN. IT IS NOT KNOWN IF ALL EVENTS ARE RELATED TO THE SAME PROCEDURE. NO INJURIES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11061085 ↗
• MalfunctionDec 22, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THREE TRIAL FEMORAL HEAD 32 L/+8 WERE FOUND BROKEN. IT IS NOT KNOWN IF ALL EVENTS ARE RELATED TO THE SAME PROCEDURE. NO INJURIES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11061018 ↗
• MalfunctionDec 22, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THREE TRIAL FEMORAL HEAD 32 L/+8 WERE FOUND BROKEN. IT IS NOT KNOWN IF ALL EVENTS ARE RELATED TO THE SAME PROCEDURE. NO INJURIES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11060987 ↗