ATTUNE 2513-12-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295438809), received between Sep 12, 2018 and Sep 17, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 17, 2025Break; Break

  WHILE BROACHING FOR THE ATTUNE REVISION TIBIAL SLEEVE, THE 12X60 SHEARED OFF THE 29MM TIBIAL SLEEVE. MANAGED TO FISH THE STEM OUT WITH A LONG GRASPER SO VERY LITTLE DELAY TO THE SURGERY AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072970 ↗
• MalfunctionJul 27, 2021Break; Break

  12X60 ATTUNE REVISION STEM SHEARED OFF A 45MM TIBIAL BROACH, LEAVING BOTH ITEMS UNUSABLE AND NEEDING REPLACEMENT. SURGEON WAS BROACHING THE TIBIA WHEN IT HAPPENED. NO REAL DELAY TO THE CASE BUT HE DID HAVE TO RETRIEVE THE BROKEN STEM TRIAL FROM THE TIBIAL CANAL. EVERYTHING WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235482 ↗
• InjuryNov 23, 2020Break; Entrapment of Device; Break; Entrapment of Device

  THE CONEXIÓN BETWEEN SLEEVE AND STEM WAS BROKEN AND THE STEM WAS LEFT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 10885118 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED THAT THE STEM TRIAL FRACTURED AT THE THREADED JUNCTION OF THE PART DURING REMOVAL OF THE BROACH IN THE TIBIA ON A SAWBONE. A SALES REPRESENTATIVE, WHO WAS UNDERGOING TRAINING THROUGH THE ATTUNE REVISION TRAINING DEMONSTRATION, OBSERVED THE FAILURE WHILE COMPLETING THE TASK. IT WAS CONFIRMED THAT THE STEM TRIAL WAS THE OLD DESIGN, WHICH WAS RELEASED WITH THE EARLY LAUNCHES OF THE ATTUNE REVISION KNEE SYSTEM (PRIOR TO THE STEM TRIALS BEING OPTIMIZED FOR USE WITH BROACHING). IT SHOULD BE NOTED THAT THE STEM TRIAL DIAMETER, IN RELATION TO THE TIBIAL CANAL, WAS INTENTIONALLY UNDERSIZED DURING THE DEMONSTRATION. THE UNDER-SIZING OF THE STEM TRIAL, COULD HAVE LED TO THE PART BEING FURTHER OFF-AXIS IN RELATION TO THE LINE OF IMPACTION, THEREFORE INCREASING THE OVERALL STRESS ON THE THREADED JUNCTION IF IT WERE TO BE SLIGHTLY LOOSE FROM THE MATING INTERFACE (BROACH). THE PART WAS RETRIEVED FROM THE SAWBONE. NO PATIENT INTERACTION AS IT OCCURRED DURING A TRAINING DEMONSTRATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7868061 ↗