ATTUNE 2545-06-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295497035), received between Oct 29, 2021 and Aug 28, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  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 22917432 ↗
• MalfunctionJun 26, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY HANDLE IS NOT RATCHETING CORRECTLY. NOTHING FURTHER TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613239 ↗
• 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. (B)(6) 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721771 ↗
• 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 (B)(6) FOR INVESTIGATION. ON (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 12721583 ↗