INSTRUMENT 31-473601Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05019279457403), received between Jan 10, 2022 and Dec 9, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE THREADED TAPERLOC HANDLE BROKE OFF IN THE STEM. NO HEALTH CONSEQUENCES OR HARM OCCURRED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760029 ↗
• MalfunctionNov 7, 2025Fracture; Fracture

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23495540 ↗
• MalfunctionJul 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PLASTIC GRIP ON THE HANDLE SPINS FREELY AND IS DIFFICULT TO REMOVE FROM THE IMPLANT. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22631262 ↗
• MalfunctionOct 14, 2024Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT THE THREADS OF THE STEM INSERTER WERE FOUND TO BE STRIPPED BEFORE THE PROCEDURE BEGAN. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439532 ↗
• MalfunctionNov 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS ON THE STEM INSERTER WERE SLIGHTLY OFF, AND IT DID NOT SPIN IN SMOOTHLY INTO THE STEM. THERE ARE NO KNOWN IMPACTS TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182940 ↗
• MalfunctionSep 8, 2023Fracture; Fracture

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17711163 ↗
• MalfunctionAug 17, 2023Fracture; Difficult to Remove; Fracture; Difficult to Remove

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568187 ↗
• MalfunctionJun 22, 2023Material Deformation; Material Deformation

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17180670 ↗
• MalfunctionJan 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT A STEM INSERTER TIP BROKE OFF INTO INTEGRAL STEM IMPLANT. WE COULD NOT REMOVE THE BROKEN PIECE SO WE HAD TO IMPLANT A ECHO STEM INSTEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13205499 ↗