ATTUNE 2545-00-138Recalls & reported problems

Summary

The FDA's MAUDE database contains 392 adverse event reports that list this exact device (DI 10603295131021), received between Jul 11, 2017 and Sep 15, 2026 — classified as 392 malfunctions.

The most frequently reported specific device problem is “Break” (347 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 25 most recent of 392 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778955 ↗
• MalfunctionAug 27, 2026Break

  It was reported that the Attune Tibial Trial Extractor instrument broke during surgery. It broke into two large fragments that were discarded. There were no reported patient or user harms. There was no significant delay. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479488 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306103 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT THE TRIAL EXTRACTOR BROKE DURING SURGERY. ALL PIECES WERE RETRIEVED. THERE WAS NO DELAY. THERE WAS NO HARM TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159677 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT THE PART OF THE TRIAL EXTRACTOR WAS SNAPPED OFF. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060260 ↗
• MalfunctionApr 21, 2026Break

  ADDITIONAL INFORMATION RECEIVED: UPON INSPECTING THE INSTRUMENT SET THAT CAME FROM A HOSPITAL TO OUR WAREHOUSE IT WAS FOUND THAT: ONE OF THE TWO PRONGS WAS BROKEN OFF. UNKNOWN WHEN AND HOW THIS HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24935969 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT THE ATTUNE TRIAL EXTRACTOR WAS RETURNED TO THE REPRESENTATIVE BY STERILE PROCESSING WITH ONE OF THE FORKS BROKEN OFF. THIS DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639642 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT END OF THE HANDLE HAD BROKEN. THIS DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558088 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT THE TIBIAL EXTRACTOR BROKE AFTER BEING USED. NO HARM TO PATIENT. NO EXTRA TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24513582 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT THE TWO FORKED ENDS OF THE TRIAL EXTRACTOR BROKE OFF WHEN REMOVING THE TRIAL. TWO PIECES HAD BROKEN OFF AND BOTH PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506266 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT TRIAL EXTRACTOR WAS BROKEN DURING CASE. IT WAS FURTHER REPORTED THAT THE TIP WAS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430159 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT TRIAL INSERT WAS BROKEN DURING REMOVAL. ALL PIECE RECOVERED. IT WAS REMOVED FROM TRAY. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248918 ↗
• MalfunctionDec 26, 2025Break; Break

  THE POLY EXTRACTOR WAS BROKEN WHEN EXTRACTING THE TRIAL POLY... ALSO THE FEMORAL IMPLANT INSERTER WAS BROKEN WHEN IMPACTING THE IMPLANT ONTO THE FEMUR. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, (B)(4), DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.TRUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897727 ↗
• MalfunctionDec 8, 2025Break; Crack; Break; Crack

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE ONE OF THE TIPS OF THE PRODUCT CRACKED AND BROKE OFF, THE OTHER SIDE CHIPPED OFF AND THAT SMALL CHIP WAS RECOVERED FROM PATIENT, BUT WAS LOST IN THE WASHER STERILIZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743591 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INSTRUMENT SNAPPED WHILE REMOVING TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697798 ↗
• MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE ATTUNE TIBIAL TRIAL EXTRACTOR HAS ONE OF THE PRONGS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693349 ↗
• MalfunctionDec 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE ATTUNE TIBIAL TRIAL EXTRACTOR HAS ONE OF THE PRONGS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693329 ↗
• MalfunctionNov 20, 2025Break; Break

  FOR THE FEMORAL IMPACTOR AND EXTRACTOR THEY BROKE IN THE PROCEDURE BUT THEY DIDN¿T AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604669 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE INSERT TRIAL EXTRACTOR BROKE OFF WHEN REMOVING THE INSERT TRIAL. ALL PARTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596726 ↗
• MalfunctionNov 10, 2025Break; Break

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR AND EXTRACTOR BROKE IN THE PROCEDURE BUT THEY DIDN¿T AFFECT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508372 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT PLASTIC TIP BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361997 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT BLACK TRIAL EXTRACTOR WAS BROKEN DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037251 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT THE TRIAL EXTRACTOR BROKE DURING SURGERY. THE SURGERY WAS NOT DELAYED DUE TO THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983871 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT THE OUTER TIP OF THE TRIAL EXTRACTOR BROKE OFF WHILE REMOVING TRIAL COMPONENTS. THE PIECE WAS REMOVED FROM THE FIELD. THE PATIENT WAS NOT AFFECTED AND SURGERY TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903313 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT THE DM LINER TRIAL BROKE, THE BLACK POLY EXTRACTOR TIP BROKE OFF, THE T-HANDLE AND CORKSCREW KEEP DISCONNECTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841041 ↗