Tornier HRS ARS1022801Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832094004), received between Jun 10, 2025 and Aug 13, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING SURGERY, TWO HRS -2 POLYETHYLENE INSERTS WERE UNABLE TO SEAT/LOCK INTO THE HRS CENTERED TRAY DESPITE BEING IMPACTED INTO PLACE. BOTH INSERTS WERE ATTEMPTED IN VIVO AND ON THE BACK TABLE AND DID NOT CONNECT, RESULTING IN THEIR DISPOSAL. THE CENTERED TRAY WAS REMOVED FROM USE, AND A NEW CENTERED TRAY WAS OPENED; HOWEVER, THE ORIGINAL TWO INSERTS AGAIN FAILED TO SEAT. AFTER A SIGNIFICANT DELAY, A THIRD INSERT ¿ A NON-VITAMIN E STANDARD PERFORM +0 POLY ¿ WAS OPENED AND SUCCESSFULLY IMPLANTED WITH AN ECCENTRIC TRAY. THE ECCENTRIC TRAY USED FOR IMPLANTATION HAD ALSO FAILED TO SEAT THE ORIGINAL TWO INSERTS.

  Patient problems: Insufficient Information

  MAUDE report 22794807 ↗
• MalfunctionJun 10, 2025Entrapment of Device; Mechanical Jam; Entrapment of Device; Mechanical Jam

  THE HRS STEM WAS USED. THE POLY WAS TRAILED AND -2 WAS SELECTED. THE FINAL IMPLANT WAS OPENED. IT WAS A STRUGGLE TO GET THE POLY TO SIT CORRECTLY, SO IT WAS TAKEN OFF WITH A FREER AND TRIED AGAIN. THE IMPLANT SUCCESSFULLY SEATED AND WHEN THE SHOULDER WAS REDUCED, THE JOINT WAS LOOSE. IT WAS DECIDED TO TAKE THE POLY OFF AND RE-TRIAL WITH A 0 POLY. TO GET THE -2 POLY OFF, A PERIPHERAL DRILL WAS USED TO DRILL IN THE CENTER OF THE IMPLANT, THEN A PERIPHERAL SCREW WAS USED TO DRILL THE POLY BUT IT DIDN¿T POP OFF. THEN A 6.5 SCREW WAS USED AND THE SAME THING HAPPENED. NEXT, A 9.5 AND AGAIN THE POLY DIDN¿T POP OFF. AT THIS POINT, AN OSTEOTOME WAS USED TO GET THE POLY OFF AND PIECES OF THE POLY WOULD COME OFF BUT NOT THE WHOLE THING. THE TRAY WITH THE TUNING FORK HAD TO BE TAKEN OFF. THERE WAS ONLY ONE 8 CENTERED HRS TRAY AT THE FACILITY SO THE POLY NEEDED TO BE OFF ON THE BACK TABLE WITH AN OSTEOTOME. THE POLY CRACKED AND ONLY PIECES OF THE POLY CAME OFF. INSTEAD, AN 8 OFFSET TRAY WAS USED SINCE THE 0 TRAY NOW HAD HALF OF A POLY STUCK IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180239 ↗