Tornier HRS ARS1023305Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00846832094516), received between Dec 3, 2025 and Jun 16, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Mechanical Jam

  IT WAS REPORTED THAT THE ARS743000 WOULD GET STUCK ON THE PROXIMAL BODY TRIALS AFTER EVERY IMPACTION. ACCORDING TO THE STRYKER REP, THIS MADE THE TRIALLING VERY DIFFICULT (NEED A WAY TO LOOSEN HOW TIGHT THE HANDLE MATES ONTO THE PROXIMAL BODY TRIALS). ADDITIONAL INFORMATION FROM THE STRYKER REP MAY 21: "I TRIED THE HANDLE ON ONE OF OUR LTC PROXIMAL BODIES AND VICE-VERSA, AND IT TURNS OUT THAT THE HANDLE IS NOT THE PROBLEM AT ALL, IT WORKED PERFECTLY. THE PROBLEM IS WITH THE NEW PROXIMAL BODY TRIALS (ARS1023301-ARS1023306). THEY WERE STICKY ON THE OLD HANDLE AS WELL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521882 ↗
• MalfunctionDec 5, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE HRS PROXIMAL BODY SPACER SCREW MALFUNCTIONED. THE SCREW WAS NOT ADVANCING AND JUST SPINNING IN THE PROXIMAL BODY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727028 ↗
• MalfunctionDec 3, 2025Difficult to Remove; Difficult to Remove

  THE NEW PROXIMAL BODIES FOR HRS ARE GETTING STUCK IN THE HANDLES. THE PHYSICIAN HAS TRIED AN OLD REVIVE HANDLE AND ORDERED A BRAND NEW HANDLE. THE PROXIMAL BODIES HAVE GOTTEN STUCK ON MULTIPLE OCCASIONS AND CAUSED THEM TO HAVE TO TAP THE STEM OFF WITH A MALLET INTRA OP. SOMETIMES THE STEM COMES WITH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709083 ↗