ATTUNE 2545-00-335Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295446484), received between Mar 28, 2024 and Jan 16, 2026 — 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.

• MalfunctionJan 16, 2026Break; Scratched Material

  IT WAS REPORTED THAT WHEN REAMING THE TIBIA FOR A TIBIAL STEM THE REAMER STARTED TO RUB UPON THE TIBIAL BASEPLATE SCRATCHING UP A RUINING BOTH THE BASE PLATE AND REAMER. BOTH WERE DEEMED BROKEN AND THROWN IN THE SHARPS BIN BY THE SURGEON. ALL METAL WAS CLEANED UP AND NEW INSTRUMENTS WERE OPENED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096316 ↗
• MalfunctionMar 28, 2024Device-Device Incompatibility; Device-Device Incompatibility

  SIZE 5 ATTUNE TIBIAL TRIAL IS DAMAGED. THE INSERT HANDLE CANNOT BE INSERTED PROPERLY. IT NEEDS TO BE REPLACED. PATIENT STATUS/ OUTCOME / CONSEQUENCES ? NO PATIENT INVOLVEMENT, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF? OTHER. DEVICE IN POSSESSION OF ? WAREHOUSE MANAGER. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.? TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18993215 ↗