ATTUNE 252307101Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295437284), received between Aug 2, 2019 and Aug 22, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Corroded” (8 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 11 most recent of 11 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 22878202 ↗
• MalfunctionJun 28, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE ATTUNE REVISION INSTRUMENTS ARE CONTAMINATED WITH RUST. THIS WAS PICKED UP POST CLEANING BY CSSD STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633692 ↗
• MalfunctionMar 28, 2024Corroded; Corroded

  IT WAS REPORTED THAT INSTRUMENTS WERE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999902 ↗
• MalfunctionOct 25, 2023Corroded; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem; Corroded; Improper or Incorrect Procedure or Method; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE FEMORAL TRIAL HAS STARTED TO RUST DUE TO INCORRECT DETERGENT USED AT THE HOSPITAL. 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, 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.:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007519 ↗
• MalfunctionJul 22, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085578 ↗
• MalfunctionJun 24, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICE RUSTED AFTER WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799688 ↗
• 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 12443977 ↗
• MalfunctionDec 1, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN SETTING THE INSTRUMENT FOR A CASE IT WAS DISCOVERED THAT THE THREADS ON BOTH TIBIAL TRIAL AND THE WEDGE WERE STRIPPED AND WOULD NOT ALLOW THE WEDGE TO BE ATTACHED TO THE TIBIAL TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929834 ↗
• MalfunctionAug 20, 2019Corroded; Corroded

  WE SENT OUR NEW ATTUNE REVISION SETS AT THE FIRST TIME TO THE CUSTOMER AND GET THEM BACK WITH SOME RUSTED AREAS. WE DON´T EXACTLY KNOW WHEN THE INCIDENT OCCURED. PATIENT STATUS / OUTCOME / CONSEQUENCES? NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8910346 ↗
• 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 8856065 ↗
• 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 8856061 ↗