NA 4831-40-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295515760), received between Mar 22, 2023 and Apr 23, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT THE 40MM HEAD TRIAL HAS BECOME DAMAGED AND NEEDS TO BE REPLACED. IT HAPPENED DURING SURGERY. THE SURGEON WHILE TRYING TO DISLOCATE THE TRIAL IMPLANTS WAS USING A BONE HOOK AS HE ALWAYS DOES. WHILE DISLOCATING, I ASSUME THE HOOK HIT THE HEAD TRIAL AND DAMAGED THE TRIAL. THE STERILE PROCESSING DEPARTMENT NOTICED THE DAMAGE WHILE REASSEMBLING THE SET AFTER WASHING AND HAS REQUESTED A NEW TRIAL. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO DELAY IN THE SURGERY AND NO FRAGMENTS OR PIECES WERE GENERATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966077 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A LARGE SCRATCH ON THE 40 1.5 TRAIL HEAD. IT WAS UNUSABLE. THE HEAD WOULD NOT SIT PROPERLY ON THE STEM ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22643084 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A LARGE SCRATCH ON THE 40 1.5 TRAIL HEAD. IT WAS UNUSABLE. THE HEAD WOULD NOT SIT PROPERLY ON THE STEM ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22643083 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A LARGE SCRATCH ON THE 40 1.5 TRAIL HEAD. IT WAS UNUSABLE. THE HEAD WOULD NOT SIT PROPERLY ON THE STEM ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22643077 ↗
• MalfunctionSep 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT LOOSE HEADBALL, KEEPS FALLING OFF TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263919 ↗
• MalfunctionSep 10, 2024Break; Break

  IT WAS REPORTED THAT HEAD TRIAL SHEARED OFF CUP.

  Patient problems: Insufficient Information

  MAUDE report 20180323 ↗
• MalfunctionAug 20, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING THE CASE, THE SCRUB NURSE NOTICED THE 40 +1.5 HEAD TRIAL HAD A GASH IN IT. THERE WAS NO ISSUE DURING THE CASE. THERE WAS NO DELAY TO THE CASE. NO ADVERSE SIDE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20003624 ↗
• 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 18398440 ↗
• MalfunctionMar 29, 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 16635688 ↗
• 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 16611706 ↗
• MalfunctionMar 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON STATES TOLERANCES ON ALL EMPHASIS 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 16594736 ↗