NA 4831-36-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295515739), received between Mar 22, 2023 and Feb 26, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT CHIPPED 36+5 HEAD TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456999 ↗
• MalfunctionNov 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ARTICULEEZE 36+5 TRIAL HEAD WAS CHEWED UP IN THE WASHER AND VERY ROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565542 ↗
• MalfunctionMay 20, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE FEMORAL TRIAL HEADS ARE SCRATCHED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355748 ↗
• MalfunctionDec 27, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE HEAD TRIALS HAD BECOME WORN OUT AND SCRATCHED OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18398385 ↗
• MalfunctionSep 25, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT TRIAL HEADS ARE SCRATCHED/RUFFED UP. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813577 ↗
• MalfunctionMar 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES BETWEEN HEAD AND NECKS OF "EMPHASIS" WERE TOO TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635839 ↗
• MalfunctionMar 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON HAD STATED HEAD AND NECK TOLERANCES ARE TOO TIGHT WITH EMPHASYS. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 16611387 ↗
• MalfunctionMar 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON HAD STATED HEAD AND NECK TOLERANCES ARE TOO TIGHT WITH EMPHASYS. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 16610054 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES BETWEEN HEAD AND NECKS OF EMPHASYS WERE TOO TIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16594036 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES ON ALL EMPHASYS TRIAL NECKS AND HEADS ARE TOO TIGHT. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592281 ↗