ATTUNE 2546-00-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295478607), received between Aug 21, 2018 and Sep 18, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Structural Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828674 ↗
• MalfunctionApr 4, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT, AND THE MODULAR STOP WAS STICKING AND WOULDN'T LOCK INTO PLACE. THERE WAS NO PROBLEM WITH THE REAMER; THE BUTTON ON THE MODULAR STOP STICKS AND WON'T RELEASE.

  Patient problems: Insufficient Information

  MAUDE report 21775462 ↗
• MalfunctionApr 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6) 2025. DURING THE PROCEDURE, THE MODULAR STOP STICKS WON'T LOCK INTO PLACE.

  Patient problems: Insufficient Information

  MAUDE report 21773744 ↗
• MalfunctionFeb 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470736 ↗
• MalfunctionOct 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE MODULAR STOP WOULD NOT ENGAGE IN REAMER. NO SURGICAL DELAY WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859802 ↗
• MalfunctionMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS, THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT PRODUCT CODE: 254600500, LOT# SO203240. THE ISSUE IS THAT IT DOES NOT MATCH ANY ECM DEVICE FOR THE PC. DEVICES ON ECM: 259807530 MODULAR BOX OSTEOTOME. PLEASE HELP US IDENTIFY WHERE THE MODULAR STOP BELONGS. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 14540301 ↗
• MalfunctionNov 30, 2021Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE MODULAR STOP WAS UNABLE TO BE REMOVED FROM THE DRILL. IT WAS REMOVED AFTER SURGERY AND IT APPEARED THE SPRING WAS MISSING. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896235 ↗
• MalfunctionNov 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THE INSTRUMENT REPORTED FOR UNKNOWN REASON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9369076 ↗
• MalfunctionJul 9, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTUNE REVISION MODULAR STOP WILL NOT LONGER SEAT OVER REAMER. NEEDS TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772416 ↗
• MalfunctionApr 4, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND NON-FUNCTIONAL AT THE OFFICE. THIS MODULAR STOP (254600500) WILL NOT FIT OVER ANY REAMER THAT THEY HAD TRIED IT ON. THEY HAD TRIED MULTIPLE REAMERS 250620102 & 250620103 A TOTAL OF 4 DIFFERENT SETS OF REAMERS. ON REAMERS 250620102 THE MODULAR STOP WILL PASS OVER THE INITIAL PART OF THE REAMER HOWEVER IT WILL NOT CONTINUE INTO THE MODULAR STOP PATH OF THE REAMER. WITH REAMER 250620103 THE MODULAR STOP WILL START INTO THE MODULAR STOP PATH BUT ONLY HALF OF THE STOP MAKES IT INTO THE CHANNEL, THEN IT STOPS. THEY HAD TRIED FLIPPING THE MODULAR STOP AROUND AND THE SAME IT TRUE WITH BOTH SIDES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8482701 ↗
• MalfunctionApr 2, 2019Break; Break

  IT WAS REPORTED THAT THE ATTUNE REVISION MODULAR STOP WAS FOUND BROKEN AT THE OFFICE. NO PATIENT INVOLVEMENT. WE WERE TESTING THE INSTRUMENT (254600500) AT THE OFFICE TO SEE IF IT WOULD FUNCTION CORRECTLY WITH THE PART 250620103. IT GLIDED DOWN THE REAMER HOWEVER IT WOULDN'T LOCK INTO PLACE. IT WOULD NEED 2 FINGERS TO PUSH DOWN THE BLACK BUTTON AND THEN A FORCE SHOULD BE APPLIED ON THE OTHER END TO GET THE ITEM TO ITS ORIGINAL POSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8474520 ↗
• MalfunctionOct 24, 2018Fitting Problem; Fitting Problem

  MODULAR DRILL STOP DOES NOT FIT ON REAMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8000069 ↗
• MalfunctionOct 24, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE MODULAR DRILL STOP DOES NOT FIT ON REAMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7999824 ↗
• MalfunctionOct 3, 2018Break; Break

  IT WAS REPORTED THAT INSTRUMENT WAS BROKEN DURING STERILIZATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7931426 ↗
• MalfunctionAug 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 7 ATTUNE REVISION MODULAR STOP PIECES DO NOT WORK WITH THE TIBIAL STEM REAMER, THEY DO NOT SLIDE DOWN TO LOCK IN. THERE WAS A MANUFACTURING PROBLEM AND IT WAS NEVER IN A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800635 ↗
• MalfunctionAug 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 7 ATTUNE REVISION MODULAR STOP PIECES DO NOT WORK WITH THE TIBIAL STEM REAMER, THEY DO NOT SLIDE DOWN TO LOCK IN. THERE WAS A MANUFACTURING PROBLEM AND IT WAS NEVER IN A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800634 ↗
• MalfunctionAug 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 7 ATTUNE REVISION MODULAR STOP PIECES DO NOT WORK WITH THE TIBIAL STEM REAMER, THEY DO NOT SLIDE DOWN TO LOCK IN. THERE WAS A MANUFACTURING PROBLEM AND IT WAS NEVER IN A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800626 ↗
• MalfunctionAug 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 7 ATTUNE REVISION MODULAR STOP PIECES DO NOT WORK WITH THE TIBIAL STEM REAMER, THEY DO NOT SLIDE DOWN TO LOCK IN. THERE WAS A MANUFACTURING PROBLEM AND IT WAS NEVER IN A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800613 ↗
• MalfunctionAug 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 7 ATTUNE REVISION MODULAR STOP PIECES DO NOT WORK WITH THE TIBIAL STEM REAMER, THEY DO NOT SLIDE DOWN TO LOCK IN. THERE WAS A MANUFACTURING PROBLEM AND IT WAS NEVER IN A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800598 ↗
• MalfunctionAug 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 7 ATTUNE REVISION MODULAR STOP PIECES DO NOT WORK WITH THE TIBIAL STEM REAMER, THEY DO NOT SLIDE DOWN TO LOCK IN. THERE WAS A MANUFACTURING PROBLEM AND IT WAS NEVER IN A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800597 ↗
• MalfunctionAug 21, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 7 ATTUNE REVISION MODULAR STOP PIECES DO NOT WORK WITH THE TIBIAL STEM REAMER, THEY DO NOT SLIDE DOWN TO LOCK IN. THERE WAS A MANUFACTURING PROBLEM AND IT WAS NEVER IN A SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800587 ↗