ATTUNE 2546-00-424Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295440222), received between Jan 18, 2019 and Oct 22, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. 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.

• MalfunctionOct 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL AND FEMORAL SLEEVE IMPACTOR WAS STICKING TO THE SLEEVES AFTER IMPACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358703 ↗
• MalfunctionAug 25, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT THE PATIENT HAD LEFT KNEE REVISION. THE TIBIAL SLEEVE IMPACTOR GOT STUCK ON THE IMPLANT. IT WAS NOTED TO HAVE MULTIPLE ABRASIONS FROM REPETITIVE USE. NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883432 ↗
• MalfunctionJul 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SLEEVE IMPACTOR IS BENT AND STUCK TO IMPLANT. THE SLEEVE IMPACTOR FROM THE ASSEMBLY TRAY IS VISIBLY BENT OVER TIME UPON INSPECTION. IT IS NO LONGER CIRCUMFERENTIAL AND STUCK TO THE TIBIA WHILE IMPACTING THE SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563651 ↗
• MalfunctionJul 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM IS STUCK INSIDE THE IMPACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540958 ↗
• MalfunctionJul 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING REVISION CASE THE ATTUNE REVISION FEMORAL SLEEVE IMPACTOR GOT STUCK ON A FEMORAL SLEEVE IMPLANT WHEN IMPACTING IT ONTO A FEMORAL CRS IMPLANT. THE SURGEON MANAGED TO WORK IT OFF THE IMPLANT AND REQUESTED A REPLACEMENT. THERE WAS NO ISSUE WITH THE IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22397134 ↗
• MalfunctionSep 10, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DURING ATTUNE REVISION SURGERY THE FEMORAL SLEEVE IMPACTOR BECAME STUCK ON THE FEMORAL SLEEVE AND HAD TO BE REMOVED WITH A VICE GRIP AND SLAP HAMMER. THIS DAMAGED THE DISTAL PART OF THE SLEEVE AND THE SURGEON WAS NOT HAPPY TO IMPLANT. HE USED A FULLY COATED FEMORAL SLEEVE (INSTEAD OF DISTALLY COATED WHICH WAS OPENED AND WAS HIS PREFERENCE). THIS INSTRUMENT IS USED FOR BOTH TIBIAL AND FEMORAL SLEEVE IMPACTION SO EACH END IS IMPACTED WITH A MALLET WHICH APPEARS TO BE DEFORMING THE INSTRUMENT. SURGICAL DELAY OF 10 MINUTES OCCURRED. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397583 ↗
• MalfunctionMar 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  SURGEON IMPACTED THE SLEEVE OVER THE STEM DURING ASSEMBLY OF ATTUNE REVISION IMPLANTS AND THE STEM BECAME STUCK IN THE IMPACTOR. I WAS UNAWARE THAT THE HOSPITAL STERILIZATION TEAM HAD BEEN UNABLE TO REMOVE IT UNTIL NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11439948 ↗
• MalfunctionOct 28, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE INSTRUMENTS APPEAR TO HAVE RUST ON THEM. NOTHING LEFT IN PATIENT. THESE ARE INSTRUMENTS FROM NASHVILLE SET 4 ATTUNE REVISION ASSEMBLY TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9247717 ↗
• MalfunctionAug 28, 2019Corroded; Corroded

  BRAND NEW ATTUNE REVISION SET SHOWING SIGNS OF RUST ON INSTRUMENTATION. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8941425 ↗
• MalfunctionJan 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  COULD NOT INSERT IMPACTION SLEEVE OVER DEFINITIVE IMPLANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8261601 ↗