ATTUNE 2506-20-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295440550), received between May 30, 2019 and Jan 16, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 9 most recent of 9 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 24096350 ↗
• MalfunctionMay 14, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE POWER CONNECTION WAS DAMAGED/BENT AND THE INSTRUMENT CAN NO LONGER CONNECT TO POWER. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017398 ↗
• MalfunctionMay 14, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE POWER CONNECTION WAS DAMAGED/BENT AND THE INSTRUMENT CAN NO LONGER CONNECT TO POWER. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017397 ↗
• MalfunctionMar 14, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE INSTRUMENT WAS DAMAGED AT CONNECTION POINT. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605684 ↗
• MalfunctionJun 28, 2024Corroded; Corroded

  THE ATTUNE REVISION INSTRUMENTS ARE CONTAMINATED WITH RUST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19637852 ↗
• MalfunctionDec 21, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT UPON INSPECTION OF INSTRUMENTS AFTER CASE DISCOVERED THAT CEMENTED TIBIAL REVISION REAMER WAS SLIGHTLY BENT AND WILL NO LONGER PASS THROUGH BUSHING FREELY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024837 ↗
• MalfunctionOct 18, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING CLEANING UP THE CASE, IT WAS NOTICED THE LONG TIBIAL DRILL USED FOR REVISION TRAY WAS STUCK INSIDE BUSHING. FINALLY GOT IT LOOSE, UPON FURTHER INSPECTION IT APPEARS TIBIAL DRILL WAS BENT SLIGHTLY. IT WILL NOT PASS THROUGH TIBIAL TOWER BUSHING. NO SURGICAL DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624738 ↗
• MalfunctionSep 8, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  STERILE SERVICES IDENTIFIED MULTIPLE INSTRUMENTS WITH RED RESIDUE PRESENT, MAINLY AFFECTING TIBIAL TRIALS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12443929 ↗
• MalfunctionMay 30, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMER AND REAMER COLLET BECAME FUSED TOGETHER WHILE REAMING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655486 ↗