ATTUNE 252305203Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295437154), received between Aug 5, 2019 and Apr 22, 2026 — classified as 10 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. 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 10 most recent of 10 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 24957150 ↗
• MalfunctionAug 22, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO PROPERLY FIX THE 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 22878186 ↗
• 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 19643594 ↗
• MalfunctionMar 28, 2024Corroded; Corroded

  IT WAS REPORTED THAT INSTRUMENTS WERE RUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996754 ↗
• 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, (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 18012268 ↗
• MalfunctionJul 22, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS ARE SHOWING RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085623 ↗
• MalfunctionJun 24, 2022Corroded; Corroded

  IT WAS REPORTED THAT THE DEVICE RUSTED AFTER WASHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799646 ↗
• 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 12443967 ↗
• MalfunctionAug 5, 2019Corroded; Corroded

  INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861930 ↗
• MalfunctionAug 5, 2019Corroded; Corroded

  INSTRUMENTS WERE SENT IN WITH VARIOUS DEGREES OF STAINING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8861928 ↗