ATTUNE 252307102Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295437086), received between Aug 2, 2019 and Aug 22, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Corroded” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO PROPERLY FIX THE TRIAL AUGMENTS IN THE TRIAL TIBIAE. THE THREADS OF THE TRIAL APPEAR TO BE COLD WELDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878210 ↗
• MalfunctionJul 1, 2024Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  ATTUNE REVISION GENERAL TIBIAL PREP TRAY CONTAMINATED WITH RUST ON SOME INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643599 ↗
• MalfunctionMar 28, 2024Corroded; Corroded

  IT WAS REPORTED THAT INSTRUMENTS WERE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997112 ↗
• MalfunctionOct 26, 2023Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE FEMORAL TRIAL HAS STARTED TO RUST DUE TO INCORRECT DETERGENT USED AT THE HOSPITAL. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP-(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4). DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(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. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012274 ↗
• MalfunctionJul 22, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085874 ↗
• MalfunctionJun 27, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE ATTUNE DEVICE HAS RUST AFTER WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14834467 ↗
• 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 12443974 ↗
• MalfunctionAug 2, 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 8856174 ↗
• MalfunctionAug 2, 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 8856169 ↗