ATTUNE 252305202Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295437055), received between Aug 5, 2019 and Apr 22, 2026 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT DURING WORKSHOPS, THERE WERE DIFFICULTIES IN MATING THE FB TEST TIBIAL BASES WITH THE LL/MR WEDGE TESTS. ACCORDING TO THE REPORT, IN SOME CASES IT WAS IMPOSSIBLE TO GET THE WEDGE TO BE 100% FIXED TO THE TIBIAL TEST, LEAVING IT SLIGHTLY LOOSE WITH A LIGHT BETWEEN BOTH COMPONENTS. IN OTHER CASES, THE WEDGE SCREW WAS FUSED TO THE TIBIAL BASE, MAKING IT IMPOSSIBLE TO DISENGAGE. IT WAS REPORTED THAT IT WAS SUSPECTED THAT SOME OF THE PARTICIPANTS WERE BEING "ROUGH" WITH THE MATERIALS. HOWEVER, AFTER TESTING, AND EVEN THOUGH THE USER WAS CAREFUL, THE SAME THING HAPPENED. ADDITIONALLY, IT WAS REPORTED THAT THE ATTUNE KNEE SYSTEM REVISION ASSEMBLY OFFSET STABILIZER X2, BROKE WHEN THE DECOUPLING OF THE DEFINITIVE IMPLANTS WAS CARRIED OUT. IN BOTH CASES, THE DEVICE BROKE AFTER COUPLING AND UNCOUPLING APPROXIMATELY 10 TIMES. IT WAS FURTHER NOTED THAT THE USE OF THE DEVICE WAS CORRECT. IT WAS REPORTED THAT DUE TO THE SIZE OF THE PLASTIC BONES, THE DEVICE WORKED WITH TIBIAL BASES 4 AND 5. THE USER HAD PROBLEMS WITH USING THE 6. HOWEVER, IF NECESSARY, IT COULD BE USED. WAS THERE ANY HARM TO THE REPORTED PATIENT OR USER? NO. WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957151 ↗
• 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 22878098 ↗
• MalfunctionMay 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL AUGMENT TRIAL GOT STUCK ON TRIAL TIBIA TRAY. THE SCREW BROKE OFF INSIDE OF TRAY. THERE WAS NO DELAY OF SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053966 ↗
• 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 19643596 ↗
• MalfunctionMar 28, 2024Corroded; Corroded

  IT WAS REPORTED THAT INSTRUMENTS WERE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992375 ↗
• 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. 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)(6) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6) DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(6) 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 18007479 ↗
• MalfunctionSep 29, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICES ARE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508360 ↗
• MalfunctionJul 22, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085591 ↗
• MalfunctionJun 24, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICE RUSTED AFTER WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799852 ↗
• 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 12443956 ↗
• MalfunctionAug 5, 2019Corroded; Corroded

  INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861925 ↗
• MalfunctionAug 5, 2019Corroded; Corroded

  INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861922 ↗