Tornier Perform Humeral System ARS1022306Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00846832094233), received between Aug 13, 2025 and Feb 20, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Device Difficult to Setup or Prepare

  THE PERFORM 2 POLY DID NOT PROPERLY SEAT INTO THE 3 PERFORM STANDARD STEM. A SECOND ONE WAS USED AND IT DIDN'T SEAT AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 24402278 ↗
• MalfunctionFeb 20, 2026Device Difficult to Setup or Prepare

  THE PERFORM -2 POLY DID NOT PROPERLY SEAT INTO THE 3 PERFORM STANDARD STEM. A SECOND ONE WAS USED AND IT DIDN'T SEAT AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 24402252 ↗
• MalfunctionOct 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  INSERT DID NOT SEAT INTO THE STEM NO MATTER HOW HARD THE PHYSICIAN TRIED. ANOTHER INSERT HAD TO BE OPENED AND USED. ABOUT 5 MINUTE DELAY OF CASE.

  Patient problems: Insufficient Information

  MAUDE report 23238930 ↗
• 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 (POLYS) WERE UNABLE TO CONNECT TO THE HRS CENTERED TRAY. BOTH INSERTS WERE IMPACTED BUT DID NOT SEAT, RESULTING IN THEIR DISPOSAL. THE CENTERED TRAY WAS THEN REMOVED FROM USE, AND A NEW CENTERED TRAY WAS OPENED; HOWEVER, BOTH ORIGINAL POLYS AGAIN FAILED TO SEAT. AFTER A SIGNIFICANT DELAY, A THIRD POLY¿A NON¿VITAMIN E STANDARD PERFORM +0¿WAS OPENED AND SUCCESSFULLY IMPLANTED WITH AN ECCENTRIC TRAY. ATTEMPTS TO SEAT THE ORIGINAL POLYS WERE MADE BOTH IN VIVO AND ON THE BACK TABLE. THE ECCENTRIC TRAY USED FOR IMPLANTATION HAD ALSO FAILED TO SEAT THE ORIGINAL TWO POLYS.

  Patient problems: Insufficient Information

  MAUDE report 22794802 ↗
• 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 (POLYS) WERE UNABLE TO CONNECT TO THE HRS CENTERED TRAY. BOTH INSERTS WERE IMPACTED BUT DID NOT SEAT, RESULTING IN THEIR DISPOSAL. THE CENTERED TRAY WAS THEN REMOVED FROM USE, AND A NEW CENTERED TRAY WAS OPENED; HOWEVER, BOTH ORIGINAL POLYS AGAIN FAILED TO SEAT. AFTER A SIGNIFICANT DELAY, A THIRD POLY¿A NON¿VITAMIN E STANDARD PERFORM +0 ¿WAS OPENED AND SUCCESSFULLY IMPLANTED WITH AN ECCENTRIC TRAY. ATTEMPTS TO SEAT THE ORIGINAL POLYS WERE MADE BOTH IN VIVO AND ON THE BACK TABLE. THE ECCENTRIC TRAY USED FOR IMPLANTATION HAD ALSO FAILED TO SEAT THE ORIGINAL TWO POLYS.

  Patient problems: Insufficient Information

  MAUDE report 22794585 ↗