ATTUNE 2546-00-426Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295440208), received between Feb 3, 2020 and Jun 17, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  REVISION KNEE: COMPLEX PRIMARY CASE USING ATTUNE REVISION PROCEDURE. HOSPITAL BORROWED TRAY ZZINAUK0868 FROM CONSIGNED SET. THE OFFSET ADAPTOR WOULD NOT STAY IN VICE AND SEEMED THAT THE TIGHTENING MECHANISM WAS CROSS-THREADED. NO AE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165015 ↗
• MalfunctionFeb 3, 2020Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE THUMB SCREW WELD WAS BROKEN ON TIBIAL ASSEMBLY STAND. REPLACEMENT SHOULD BE SEND TO (B)(6). THIS WAS AN OFFICE INSTRUMENT SET. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9661565 ↗