ATTUNE 2504-40-128Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295442639), received between Oct 1, 2021 and Apr 29, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionApr 29, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ATTUNE REV FEMORAL BOX TRIAL SIZE 8 LEFT SCREW HAD STRIPPED CAUSING THE DEVICE NOT TO SCREW INTO CUT TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031669 ↗
• MalfunctionOct 1, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CUT THROUGH FEMORAL TRIAL SCREW HOLE IS STRIPPED OUT NOT ALLOWING THE POSTERIOR BOX TRIAL TO SCREW ONTO THE FEMORAL TRIAL. THE SCREW ON THE POSTERIOR BOX TRIAL IS STRIPPED AND NOT SCREWING ONTO THE FEMORAL CUT THROUGH TRIAL. THIS OCCURRENCE DID NOT ADD ANY ADDITIONAL TIME TO THE PROCEDURE. THERE WERE NO PARTS LEFT BEHIND. THESE 2 ITEM AS NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561807 ↗