ATTUNE 2513-18-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295438892), received between Jul 3, 2018 and Apr 29, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 29, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE STEM TRIAL THREADS BROKE OFF AT THE SLEEVE JUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031273 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED STEM TRIAL BROKE AT BASE LEAVING THREADS IN BROACH TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867428 ↗
• MalfunctionDec 15, 2022Break; Break

  IT WAS REPORTED THAT THREADED PART OF THE TIP OF STEM TRIAL BROKE OFF WHEN TAKING IT OFF BROACH TRIAL. NO PIECES WERE LEFT IN PATIENT. THERE WAS NO DELAY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15990446 ↗
• MalfunctionNov 16, 2022Break; Break

  IT WAS REPORTED THAT THE REVISION STEM TRIAL BROKE INSIDE OF THE BROACH WHILE BROACHING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15807077 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT THE STEM TRIAL BROKE. THE THREADED PORTION JUST ABOVE THE STEM TRIAL SNAPPED. THE THREADED BROKEN PIECE REMAINED IN THE 29 SLEEVE. ALL PIECES ACCOUNTED FOR AND THE CASE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152198 ↗
• MalfunctionJul 13, 2022Break; Break

  IT WAS REPORTED THAT THE 18MM STEM TRIAL THREADED CONNECTION WAS BROKEN. THIS INSTRUMENT WAS NOT USED IN SURGERY. IT WAS DISCOVERED DURING AN OFFICE IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001886 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS REPORTED THAT THE18MM TRIAL STEM BROKE AT THREAD/PILOT JUNCTION. ALL PIECES WERE ACCOUNTED FOR. THERE IS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928319 ↗
• MalfunctionDec 20, 2021Break; Break

  ATTUNE REVISION 18MMX60MM STEM TRIAL BROKE OFF IN THE TIBIA WHILE BROACHING THE TIBIA TO ACCEPT A TIBIAL SLEEVE. THE STEM TRIAL BROKE RIGHT WHERE THE MALE THREADS MEET THE TRIAL ITSELF WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 1, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? YES.

  Patient problems: Insufficient Information

  MAUDE report 13044314 ↗
• MalfunctionMar 26, 2021Break; Break

  IT WAS REPORTED THAT THE THREADS FROM THE 18X60 ATTUNE REVISION KNEE TRIAL BROKE OFF INTO THE 45 TIBIAL BROACH. ALL PARTS WERE ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574721 ↗
• MalfunctionSep 22, 2020Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE THREADS BROKE OFF THE BODY OF THE STEM AND THIS SHOULD BE IDENTIFIED WHEN THE PRODUCT IS RETURNED.

  Patient problems: No Code Available

  MAUDE report 10566860 ↗
• MalfunctionJul 3, 2018Break; Break

  IT WAS REPORTED THAT DURING REVISION THE STEM DRILL BROKE OFF THE BROACH. THE STEM TRIAL WAS STUCK IN THE PATIENTS TIBIA AND IT WAS RETRIEVED WITHOUT HAVING ANY CAUSE OR DAMAGE TO PATIENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. SURGICAL DELAY OF 20-30 MINUTES.

  Patient problems: Not Applicable

  MAUDE report 7658879 ↗