ATTUNE 252303101Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295437246), received between Aug 5, 2019 and Aug 21, 2025 — classified as 11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 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 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 22863768 ↗
• 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 19643608 ↗
• MalfunctionMar 28, 2024Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS WERE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994786 ↗
• 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. 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. (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. (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.: TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18012092 ↗
• MalfunctionSep 29, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICE HAS RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503585 ↗
• MalfunctionJul 13, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001347 ↗
• MalfunctionJun 24, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICE RUSTED AFTER WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799949 ↗
• 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 12443935 ↗
• 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 8910343 ↗
• 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 8861197 ↗
• 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 8861193 ↗