ATTUNE 2504-40-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295442899), received between Dec 12, 2018 and Sep 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  It was reported that the Femoral Box Cut Guide broke during surgery. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856705 ↗
• MalfunctionFeb 17, 2026Break

  BROKEN KNEE INSTRUMENTS. PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367066 ↗
• MalfunctionJun 7, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE BOX PLATFORM WAS BENT WHILE REMOVING IT FROM TRIAL IN SPD. NO ADDITIONAL INFORMATION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11950392 ↗
• MalfunctionDec 12, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  (B)(6). (B)(4). THE BOX TRIAL PLATFORM HAS PLAY ON THE CTT AND THIS COULD ANGLE YOUR BOX CUT OFF. AN UNSPECIFIED NUMBER OF TRIALS CHECKED AT THE LAB, AND THE SAME PLAY WAS OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8155517 ↗