ATTUNE 2546-00-421Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295440345), received between Nov 2, 2018 and Jul 3, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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.

• MalfunctionJul 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE WRENCH IS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393372 ↗
• MalfunctionAug 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE TORQUING/TIGHTENING THE STEM TO THE SLEEVE DURING ASSEMBLY, THE SLEEVE WRENCH BECAME STUCK TO THE SLEEVE. THE SURGEON WAS ABLE TO REMOVE IT WITHOUT FURTHER ISSUE BUT THE WRENCH SHOULD NOT BECOME BOUND UP ON THE IMPLANT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939317 ↗
• MalfunctionAug 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY ISSUE WITH THE SLEEVE? NO B. WAS THERE ANY PATIENT HARM/CONSEQUENCE RELATED TO THE EVENT? NO C. WAS THERE ANY SURGICAL DELAY DUE TO REPORTED EVENT? - A SMALL DELAY WHILE DR FOSTER WORKED THROUGH THE EVENT DESCRIBED ABOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906123 ↗
• MalfunctionJun 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SLEEVE WAS SLIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521850 ↗
• MalfunctionMay 16, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE WRENCH IN THE ATTUNE REVISION FEMORAL BROACHING TRAY IS STARTING TO STRIP. THERE WAS NO ADDITIONAL TIME ADDED TO CASE. PATIENT WASN'T INJURED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407723 ↗
• MalfunctionNov 2, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING ASSEMBLY OF THE FEMORAL ATTUNE SLEEVE STEM CONSTRUCT, THE SLEEVE WRENCH WOULD NOT STRIP/SLIP AROUND AS THE SURGEON TORQUED IT WITH THE TORQUE WRENCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032530 ↗