ATTUNE 2544-00-522Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295423737), received between May 16, 2018 and May 21, 2026 — classified as 2 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (37 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT TWO ATTUNE DEVICES WERE BROKEN DURING PROCESSING AND NOT DURING SURGERY. NO PATIENTS WERE AFFECTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244231 ↗
• MalfunctionSep 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING PRE-SURGICAL CHECK OF THE INSTRUMENTS IT WAS NOTED THAT THE OUTRIGGER SLIDE CUTTING BLOCK SLIP COMPONENT OF THE ATTUNE DISTAL FEMORAL JIG WAS NOT CONNECTING TO THE DISTAL FEMORAL CUTTING BLOCK LIKE IT SHOULD. TWO DIFFERENT CUTTING BLOCK CLIPS WERE USED TO CONNECT TO THE DISTAL CUTTING BLOCK; NEITHER WERE ABLE TO CONNECT TO THE CUTTING BLOCK WITHOUT ADDITIONAL MANUAL MANIPULATION OF THE CUTTING BLOCK CLIP. BOTH CLIPS WERE ABLE TO CONNECT TO A DIFFERENT DISTAL CUTTING BLOCK WITH NO ISSUES. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965319 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN INSTRUMENT ON AN UNKNOWN DATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936345 ↗
• MalfunctionApr 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ONE OF THE MIDDLE HOLES ON THE DISTAL CUTTING BLOCK IS SO WORN OUT THAT THE PINS WON'T GO IN CORRECTLY.

  Patient problems: Insufficient Information

  MAUDE report 21763114 ↗
• MalfunctionFeb 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  THE ATTUNE STERILE PINS STUCK IN THE PIN HOLE OF THE CUT BLOCK AND THIS WAS UNABLE TO BE REMOVED. ONLY DELAY TO SURGERY WAS GETTING ANOTHER TRAY FOR THE CUT BLOCK, BUT THERE WAS NO ADVERSE AFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437271 ↗
• MalfunctionFeb 5, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING PINNING OF THE DISTAL FEMUR CUTTING BLOCK, IT WAS DISCOVERED THAT A BURR WAS IMPEDING THE PINS ABILITY TO PASS THROUGH THE MIDDLE HOLE. ALTERNATE HOLE ON THE CUTTING BLOCK WAS USED INSTEAD. THERE WERE NO SURGICAL DELAY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21317626 ↗
• MalfunctionJan 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PINS WERE GETTING STUCK IN THE PIN HOLE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21161201 ↗
• MalfunctionDec 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED DURING PINNING OF THE DISTAL CUTTING BLOCK ONE OF THE HOLES SEEMED TO HAVE A BURR. SURGERY WAS DELAYED 5 MINUTES. ALTERNATE SET WAS OPENED. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20912668 ↗
• MalfunctionNov 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT ON (B)(6) 2024. WHILE PINNING THE BLOCK, PIN GOT STUCK AND BROKE OFF LEAVING PART OF THE PIN STUCK IN THE BLOCK. NO DELAYS. NOTHING LEFT IN PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20750471 ↗
• MalfunctionNov 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO CONSEQUENCES TO THE PATIENT AND NO SURGICAL DELAY.

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

  MAUDE report 20613758 ↗
• MalfunctionNov 4, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PIN BROKE OFF DURING SURGERY AFTER CUTS WERE MADE AND THERE WAS NO IMPACT ON THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604852 ↗
• MalfunctionOct 31, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ATTUNE DISTAL FEMORAL CUTBLOCK HAS A FAULTY MIDDLE PIN HOLE FROM CONTINUOUS SMOOTH PIN CONTACT AND NO LONGER ALLOWS A SMOOTH PIN TO PASS THROUGH IT. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20579155 ↗
• MalfunctionOct 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING PINNING OF THE DISTAL CUTTING BLOCK A PIN HOLE WAS FOUND TO BE BLOCKED AND NOT ABLE TO HAVE A PIN PASS THROUGH. THERE WAS A TWO MINUTES OF SURGICAL DELAY AS ALTERNATE SET WAS OPENED AND USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20411856 ↗
• MalfunctionSep 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DISTAL CUTTING BLOCK IS MISSHAPEN AND SHEARED DRILL PIN. PATIENT DELAY APPROXIMATE 5 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 20223067 ↗
• MalfunctionJul 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ADAPTOR DOES NOT ENGAGE CUT BLOCK.

  Patient problems: Insufficient Information

  MAUDE report 19782144 ↗
• MalfunctionJun 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  POST DISTAL CUTS, SURGEON FOUND REMOVING THE DISTAL CUTTING JIG DIFFICULT TO REMOVE FROM THE JIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19570630 ↗
• MalfunctionJun 6, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT CROSS PIN INSIDE WAS NOT SMOOTH AND CAUSING PIN TO NOT ADVANCE.

  Patient problems: Insufficient Information

  MAUDE report 19476554 ↗
• MalfunctionApr 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIN GOT STUCK IN DISTAL FEMORAL CUTTING BLOCK. AN ALTERNATIVE TRAY NEEDED TO BE OPENED. SOMETHING WAS CATCHING ON PINS ON PIN HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19050893 ↗
• MalfunctionApr 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS PINNING THE DISTAL FEMORAL BLOCK AND STARTED PUTTING THE PIN IN AT AN ANGLE. THE PIN BECAME STUCK IN THE CUTTING BLOCK. STAFF OPENED ANOTHER CUTTING BLOCK AND THE REST OF THE CASE PROCEEDED AS NORMAL. THERE WAS NO ISSUE TO THE PATIENT. A TOTAL OF LESS THAN ONE MINUTE DELAY WAS OBSERVED. A PORTION OF THE PIN DID BREAK IN SPD AFTER THE CASE WHEN THE STAFF TRIED TO REMOVE THE PIN FROM THE BLOCK. THERE WERE NO PIECES BROKEN INTRA OP, AND THEREFORE NO PIECES TO RETRIEVE FROM THE PATIENT. THE BLOCK IS BEING RETURNED WITH THE PIN COLD WELDED IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018290 ↗
• MalfunctionMar 18, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE ATTUNE DISTAL FEMORAL CUTTING BLOCK IS BROKEN. THE ATTUNE PIN WAS CROSS THREADED AND SNAPPED IN THE CUTTING BLOCK HOLE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 2, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO,

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

  MAUDE report 18920164 ↗
• MalfunctionFeb 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DISTAL FEMORAL CUT GUIDE, CONSISTING OF THREE PIECES, IS FIXED IN THE BONE, BUT AT THE TIME OF REMOVING IT FROM JAMMING AND FOUND IT DIFFICULT IF RELEASE, ONCE IT WAS ACHIEVED IT WAS REMOVED. IT WAS REASSEMBLED AND FIXED AGAIN AND THIS TIME IT WAS EASIER TO RELEASE. SURGERY WAS EXTENDED FOR A COUPLE OF ADDITIONAL MINUTES BY REPEATING STEPS. THE SURGERY WAS COMPLETED WITHOUT MORE ISSUES. ALSO, REPORTED THAT THE DISTAL CUT GUIDE, THE ARMED GUIDE AND THE PIECE THAT POINTS TO THE BLACK ARROW IS THE ONE THAT STUCK AND COULD NOT BE RELEASED.

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

  MAUDE report 18756634 ↗
• MalfunctionJan 22, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DISTAL FEMORAL CUT BLOCK HAD A BURR INSIDE THE MIDDLE PINHOLE, NOT ALLOWING A PIN TO PASS THROUGH. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551438 ↗
• MalfunctionDec 7, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE ATTUNE DISTAL FEMORAL CUTTING BLOCK HAS WARPED OVER THE YEARS AND DOES NOT PROPERLY CONNECT TO THE DISTAL FEMORAL CUTTING JIG. NO TIME ADDED TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282788 ↗
• MalfunctionNov 17, 2023Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP STATES THAT THE ALLEGATION IS, THE SURGEON BELIEVES THE DISTAL FEMORAL BLOCK OBLIQUE PIN HOLE IS DAMAGED, AND REQUESTED A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158832 ↗
• MalfunctionOct 10, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DISTAL FEMORAL CUT BLOCK DEVELOPED A BURR IN THE PIN HOLE CAUSING SMOOTH PINS TO CATCH THIS BURR. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17905568 ↗