ATTUNE 2546-00-428Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295440307), received between Feb 7, 2018 and Jul 30, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086865 ↗
• MalfunctionApr 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING IMPLANT ASSEMBLY THE SURGEON NOTICED THE WRENCH NO LONGER FIT TIGHTLY AGAINST THE STEM. WHEN HE ENGAGED THE WRENCH WITH ENOUGH FORCE TO MAKE TO REQUIRED LOAD THE WRENCH SLIGHTLY SLIPPED AROUND THE FITTINGS. UPON CLOSER EVALUATION AFTER THE CASE, IT WAS FOUND THAT ENOUGH WEAR ON THE INSIDE OF THE WRENCH ALLOWED SLIGHT SLIPPAGE. THE WRENCH WAS REMOVED FROM SERVICE. THERE WAS NO SURGICAL DELAY. NO PIECES WERE LEFT BEHIND IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924800 ↗
• MalfunctionJun 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WRENCH WAS SLIPPING AND NEEDED TO BE REPLACED. THE IMPACTOR WAS WORN OUT AND NEEDED TO BE REPLACED AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134885 ↗
• MalfunctionJun 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WRENCH IS SLIPPING AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22132325 ↗
• MalfunctionSep 10, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  THE STEM OF THE FEMORAL COMPONENT BECAME DAMAGED DURING TORQUEING AND THE MOUNTING KEY IS SEEN TO BE ROLLED IN ITS HEXAGON, WHICH COULD ALTER THE FIXING OF THE STEM.

  Patient problems: Insufficient Information

  MAUDE report 20179806 ↗
• MalfunctionMar 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE WRENCH SPRUNG WHEN TIGHTENING TIBIAL STEM ONTO BASEPLATE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524525 ↗
• MalfunctionAug 9, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE WRENCH ATTACHMENT IS SPRUNG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190988 ↗
• MalfunctionOct 8, 2021Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  1. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? 2. THE DER IS MARKED YES FOR PIECES BEING RETRIEVED FROM PATIENT. PLEASE VERIFY IF THIS WAS MARKED BY MISTAKE OR IF THERE WERE PIECES BROKEN OFF FROM THE INSTRUMENT. IF YES, DID IT BREAK INTO 2 OR MORE PIECES? 3. PLEASE CONFIRM IF THE WRENCH WAS REALLY WORN. IF YES, WHAT FEATURE OF THE WRENCH WAS WORN AND NOT MAKING IT FUNCTION AS INTENDED? ANSWER: 1. NO ADVERSE CONSEQUENCES TO THE PATIENT. 2. NO PIECES BROKE OFF AT ALL. THE INSTRUMENT PARTS INVOLVED WERE BEING SENT BACK JUST FOR YOUR REVIEW. 3. I COULDN¿T BE CERTAIN IF THE WRENCH WAS IN FACT WORN DOWN SO I SENT IT BACK FOR YOUR REVIEW.

  Patient problems: Insufficient Information

  MAUDE report 12599465 ↗
• MalfunctionJun 7, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE WRENCH IS WORN ON AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946971 ↗
• MalfunctionNov 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT UPON TIGHTENING THE FINAL STEM, THE TORQUE WRENCH SLIPPED DURING THE PROCESS. APPEARS TO BE STRIPPED FROM USE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10891548 ↗
• MalfunctionJul 10, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ATUN REV ASSEM ADAPTOR GOT STRIPPED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256087 ↗
• MalfunctionMar 2, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE WRENCH IS STRIPPED. THERE WAS NOTHING LEFT IN PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9777719 ↗
• MalfunctionMay 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THERE WAS AN INSTRUMENT THAT APPEARED TO NOT WORK CORRECTLY. THE 245600428 (STEM WRENCH) GOT STUCK ON THE STEM IMPLANT AND IT WAS DIFFICULT TO SEPARATE. IF YOU LOOK ON THE INSIDE OF THE WRENCH YOU CAN SEE WHERE THE CORNERS OF THE STEM BOUND WITH THE WRENCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583755 ↗
• MalfunctionFeb 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TOLERENCE BETWEEN WRENCH AND IMPLANT CAUSED DAMAGE TO THE STEM PROSTHESIS.NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247756 ↗