ATTUNE 252305103Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295437161), received between Aug 2, 2019 and Aug 21, 2025 — classified as 10 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 10 most recent of 10 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 22861605 ↗
• 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 19643603 ↗
• MalfunctionMar 28, 2024Corroded; Corroded

  IT WAS REPORTED THAT INSTRUMENTS WERE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997262 ↗
• 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.: TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18007509 ↗
• MalfunctionSep 29, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICES ARE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508672 ↗
• MalfunctionJul 22, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085614 ↗
• MalfunctionJun 24, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICE RUSTED AFTER WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799775 ↗
• 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 12443945 ↗
• 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 8856165 ↗
• 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 8856162 ↗