ATTUNE 252303103Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295437147), received between Aug 5, 2019 and Aug 21, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Corroded” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED DURING A WORKSHOP IT WAS NOT POSSIBLE TO PROPERLY FIX THE THE TRIAL AUGMENTS IN THE TRIAL TIBIAE. IT SEEMS THAT SOMETHING IS WRONG WITH THE TREADS OF THE TRIAL. THEY ARE SOMEHOW COLD WELDED. THE INSTRUMENTS WERE DIFFICULT TO SCREW TOGETHER AND STOPPED WORKING BEFORE THEY ARE FIRMLY CONNECTED. AT THIS POINT, THE ITEMS COULD NO LONGER BE UNSCREWED. (B)(4) IS RELATED TO, (B)(4) - 10 IPS, (B)(4) - 5 IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864081 ↗
• MalfunctionApr 3, 2025Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT TARNISHING WAS FOUND ON THE INSIDE OF THE TRIALS. IT WAS UNABLE TO BE REMOVED WITH CLEANING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21764922 ↗
• MalfunctionOct 8, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL AUGMENT GOT CROSS THREADED TO TIBIAL TRIAL.

  Patient problems: Insufficient Information

  MAUDE report 20398568 ↗
• MalfunctionJun 28, 2024Corroded; Corroded

  THE ATTUNE REVISION INSTRUMENTS ARE CONTAMINATED WITH RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637262 ↗
• MalfunctionMar 28, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS WERE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994926 ↗
• MalfunctionOct 26, 2023Corroded; Improper or Incorrect Procedure or Method; Corroded; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE FEMORAL TRIAL HAS RUSTED AS THE HOSPITAL USED THE WRONG DETERGENT. PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014946 ↗
• MalfunctionSep 29, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICES ARE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508402 ↗
• MalfunctionJul 13, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001350 ↗
• MalfunctionJun 24, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICE RUSTED AFTER WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799929 ↗
• MalfunctionSep 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  STERILE SERVICES IDENTIFIED MULTIPLE INSTRUMENTS WITH RED RESIDUE PRESENT, MAINLY AFFECTING TIBIAL TRIALS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443937 ↗
• MalfunctionAug 5, 2019Corroded; Corroded

  INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING. LOAN KIT REFERENCE: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861192 ↗
• MalfunctionAug 5, 2019Corroded; Corroded

  INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING. LOAN KIT REFERENCE: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861191 ↗