ATTUNE 2546-00-447Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295440390), received between Feb 9, 2021 and Jun 25, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ROD BENT DURING EXTRACTION AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327495 ↗
• MalfunctionJan 6, 2025Material Deformation; 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 21079837 ↗
• 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 20439772 ↗
• MalfunctionDec 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE REMOVAL OF THE FEMORAL SLEEVE, THE FEMORAL SLEEVE SEPARATE PUSHROD WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18400368 ↗
• MalfunctionJun 17, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14737858 ↗
• MalfunctionJun 17, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14737800 ↗
• MalfunctionJun 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ROD BENT AFTER USE. PATIENT NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14655982 ↗
• MalfunctionFeb 9, 2021Break; Material Deformation; Break; Material Deformation

  THE SURGEON CARRIED OUT AN ATTUNE REVISION REMOVAL (FEMORAL/TIBIAL COMPONENTS WITH FULLY PORUS SLEEVES AND 60 MM PRESSFIT STEMS). AFTER USING THE FEMORAL SLEEVE SEPARATOR ROD/SEPARATOR BASE. THE ROD WAS BENT IN THE BASE, THE SURGEON ATTEMPTED TO BEND THE ROD STRAIGHT AND THEN BROKE THE TIP OF THIS ROD ON THE SURGICAL TABLE. WHERE THE REMAINING ROD WAS STUCK IN THE SEPARATOR BASE. AFTER ATTEMPTING TO TRY AND REMOVE THIS, THE DECISION WAS MADE TO SEND IT BACK TO THE DEPOT AND LET LOAN KITS AND INSPECTION REMOVE IT. THE PATIENT HAD AN INFECTION. THE PRIMARY SURGERY WAS BELIEVED TO BE LAST YEAR IN PRIVATE PRACTICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301751 ↗