ATTUNE 2545-06-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295496984), received between Oct 29, 2021 and Jan 5, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT RIGHT TIBIAL TOWER IS SLIPPING SLIGHTLY WHEN TENSIONED. NOT GRABBING WHERE IT SHOULD BE SET. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958223 ↗
• MalfunctionAug 28, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED FROM THE SURGEONS THAT THE CALIBRATION IS OFF ON ALL OF THESE ITEMS. THE MALFUNCTION DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22917431 ↗
• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  INTRAOPERATIVELY IT WAS NOTICED THAT THE TWO INSTRUMENTS BELONGING TOGETHER CANNOT BE CONNECTED/ASSEMBLED. NO PATIENT HARM REPORTED, NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310220 ↗
• MalfunctionOct 29, 2021Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement

  COMPLAINT LINK TO THE COMPLAINT (B)(4): SECOND COMPLAINT OPEN REGARDING THE INCIDENT OCCURRED "A FEW WEEKS AGO" : "END OF AFTERNOON, THE SURGEON HAD ISSUE TO DISTRACT THE KNEE WITH THE THEMIS. THE INSTRUMENT WAS INTRODUCED IN EXTENSION, THE SURGEON WAS SUPPORTING THE BACK OF THE KNEE BUT WHEN HE WAS QUIZZING THE HANDLE TO DISTRACT THE SPRING WAS COMPRESSING (UP TO MAXIMUM) BUT THE TENSER WAS NOT APPLYING ANY TENSION ON THE ARTICULATION (HE WAS NOT MOVING); THE TENSER HAD SPACE IN THE ARTICULATION, IT WAS MOVING A BIT BUT WAS NOT DISTRACTING. OUT SIDE THE KNEE THE TENSER WAS DISTRACTING WHEN SQUEEZING THE HANDLE BUT IT WAS A BIT DIFFICULT TO BRING IT BACK TO 0 AND WHEN THE SALES REP WAS MOUNTING IT SHE FILLED DIFFICULT TO PUT THE FEMORAL PART IN THE TIBIAL PART. THIS PROBLEM HAPPENED ALREADY ONCE A FEW WEEK AGO WITH THE SAME PROBLEM. BUT THEY WERE NOT THINKING OF ISSUE WITH THE THEMIS. THE SALES REP COME ON (B)(6) 2021 TO SEE WHAT WAS HAPPENING. IT WAS A RIGHT KNEE. NO ADDITIONAL TIME OF THE SURGERY AND NO NEGATIVE EFFECT FOR THE PATIENT THE SURGEON USED THE SPACER BOCK TO CHECK THE SPACES. THE THEMIS IS ON CONSIGNMENT, IT WILL BE SENT BACK TO SAINT PRIEST FOR INVESTIGATION. ON (B)(

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721721 ↗
• MalfunctionOct 29, 2021Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement

  END OF AFTERNOON, THE SURGEON HAD ISSUE TO DISTRACT THE KNEE WITH THE THEMIS. THE INSTRUMENT WAS INTRODUCED IN EXTENSION, THE SURGEON WAS SUPPORTING THE BACK OF THE KNEE BUT WHEN HE WAS QUIZZING THE HANDLE TO DISTRACT THE SPRING WAS COMPRESSING (UP TO MAXIMUM) BUT THE TENSER WAS NOT APPLYING ANY TENSION ON THE ARTICULATION (HE WAS NOT MOVING); THE TENSER HAD SPACE IN THE ARTICULATION, IT WAS MOVING A BIT BUT WAS NOT DISTRACTING. OUT SIDE THE KNEE THE TENSER WAS DISTRACTING WHEN SQUEEZING THE HANDLE BUT IT WAS A BIT DIFFICULT TO BRING IT BACK TO 0 AND WHEN THE SALES REP WAS MOUNTING IT SHE FILLED DIFFICULT TO PUT THE FEMORAL PART IN THE TIBIAL PART. THIS PROBLEM HAPPENED ALREADY ONCE A FEW WEEK AGO WITH THE SAME PROBLEM. BUT THEY WERE NOT THINKING OF ISSUE WITH THE THEMIS (SEE COMPLAINT (B)(4)). THE SALES REP COME ON (B)(6) 2021 TO SEE WHAT WAS HAPPENING. IT WAS A RIGHT KNEE. NO ADDITIONAL TIME OF THE SURGERY AND NO NEGATIVE EFFECT FOR THE PATIENT THE SURGEON USED THE SPACER BOCK TO CHECK THE SPACES. THE THEMIS IS ON CONSIGNMENT, IT WILL BE SENT BACK TO SAINT PRIEST FOR INVESTIGATION. (B)(6) 2021 THE SURGEON DID A SECOND KNEE WITH THEMIS AND IT WORKS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721617 ↗