ATTUNE 2546-00-440Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295440482), received between Jun 10, 2022 and Jun 10, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT FEMORAL SLEEVE SEPARATOR BASE WAS CROSS THREADED INTO THE ATTUNE REVISION FEMUR. THE SURGEON WAS NOT ABLE TO REMOVE IT FROM THE FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25456885 ↗
• MalfunctionJan 6, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING A KNEE SURGERY ON (B)(6) 2024, THE THREADS ON THE ASSEMBLY SLEEVE SEPARATOR WAS DAMAGED AND WOULD NOT THREAD INTO THE SLEEVE. THE PUSH ROD WAS ALSO BENT. THE SURGERY WAS NOT DELAYED DUE TO THESE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079809 ↗
• MalfunctionOct 14, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THE ADAPTOR AND SEPARATOR BASE ITEMS WOULD NOT THREAD INTO ATTUNE REVISION FEMUR AS PER SURGICAL TECHNIQUE STATES. ATTUNE REVISION 6MM HEX DRIVER WOULD ALLOW ITEMS TO CONNECT; THERE IS POSSIBLE DAMAGE TO THREADS OR CONNECTION POINT WITH HEX DRIVER. THE SEPARATOR ROD GOT BENT IN THE PROCESS OF TRYING TO USE THE KIT. THE EVENT WAS MANAGED BY USING OSTETOTOMES, GIGLI SAWS AND ALTERNATIVE INSTRUMENTATION TO TRY AND REMOVE. THE PROCEDURE WAS PROLONGED BY TEN (10) MINUTES; THERE WAS NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439755 ↗
• MalfunctionDec 5, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE FEMORAL SLEEVE SEPARATOR BASE DIDN'T SEEM TO EVER THREAD INTO THE FEMUR CORRECTLY AND WOULD PULL OFF PRIOR TO DISENGAGEMENT. TIBIAL SLEEVE SEPARATOR BASE AND TIBIAL SLEEVE SEPARATOR WEDGE STAYED ATTACHED TO THE TIBIAL TRAY. THE THREADS WERE STRIPPED ON THE TAPER BASE. THERE WAS A SURGICAL DELAY OF 2 HOURS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915823 ↗
• MalfunctionJun 17, 2022Naturally Worn; Naturally Worn

  CROSS THREADED AND PUSH PINS BROKE IN HALF. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14737795 ↗
• MalfunctionJun 10, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE SEPARATOR BASE SCREW THREAD DAMAGED SO DID NOT ATTACH TO THE FEMORAL COMPONENT. PATIENT NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655928 ↗