ATTUNE 2504-40-124Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295442554), received between Apr 3, 2019 and Sep 9, 2025 — 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.

• MalfunctionSep 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT AFTER COMPLETION OF TOTAL KNEE REPLACEMENT (TKR) REVISION, AN ATTEMPT WAS DONE TO DISASSEMBLE THE FEMORAL BROACH FROM THE FEMORAL BOX GUIDE VIA THE FEMORAL BROACH BOLT BUT WERE UNSUCCESSFUL DUE TO THE TORQUE LIMITING HEX DRIVER NOT HAVING ENOUGH TORQUE TO DISASSEMBLE. DURING THE CASE SURGEON HAD USED PLIERS TO TIGHTEN THE FEMORAL BROACH BOLT - BYPASSING THE TORQUE LIMITER. SINCE THE BOLT HAS BEEN TORQUED HIGHER THAN THE TORQUE LIMITING HANDLE IT WAS IMPOSSIBLE TO UNSCREW AFTER THE CASE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006478 ↗
• MalfunctionApr 3, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED DURING SAW BONES WORKSHOP TRAINING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480280 ↗