ATTUNE 2544-11-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 160 adverse event reports that list this exact device (DI 10603295493549), received between May 8, 2019 and Sep 30, 2026 — classified as 160 malfunctions.

The most frequently reported specific device problem is “Break” (91 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 160 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946105 ↗
• MalfunctionSep 28, 2026Contamination /Decontamination Problem

  It was reported that the attune system impactor had cement that was not able to be removed in its scratches. It was reported that the device could not be processed by Sterile Processing (SPD). It was reported that the event did not happen in surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50912818 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451489 ↗
• MalfunctionAug 14, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260175 ↗
• MalfunctionAug 7, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50174656 ↗
• MalfunctionJun 25, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA), THE IMPACTOR BROKE WHILE IMPACTING FEMUR. ACCORDING TO THE REPORTER, THE DEVICE BROKE INTO TWO PIECES. ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25626186 ↗
• MalfunctionJun 19, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT IMPACTORS HELD CEMENT DURING USE DUE TO WEAR. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562012 ↗
• MalfunctionJun 19, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT IMPACTORS HELD CEMENT DURING USE DUE TO WEAR. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562008 ↗
• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT TIP OF THE BLACK FEMORAL IMPACTOR FELL OFF WHILE IMPACTING TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25520200 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT PLASTIC ON BLACK IMPACTION HANDLE IS FLAKING OFF. USED A DIFFERENT INSTRUMENT, NO HARM TO THE PATIENT, NO DELAY IN CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484530 ↗
• MalfunctionJun 11, 2026Material Deformation

  IT WAS REPORTED THAT THE IMPACTORS WERE DAMAGED. IT WAS REPORTED THAT THERE WAS A DENT AT THE DISTAL END. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477125 ↗
• MalfunctionJun 5, 2026No Apparent Adverse Event

  INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409601 ↗
• MalfunctionJun 2, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING STERILE PROCESSING A SYSTEM IMPACTOR COULD NOT REMOVE THE CEMENT OFF OF MAKING IT A STERILITY CONTENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25364465 ↗
• MalfunctionJun 1, 2026Break; Crack; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHEN OPENING THE TRAYS FOR THE CASE, THE TIBIAL IMPACTOR HAS CRACKS AND CHIPS WHICH CANNOT BE PROPERLY CLEANED AND THERE IS CEMENT IN CHIPS AND CRACKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355218 ↗
• MalfunctionMay 13, 2026Crack; Illegible Information

  IT WAS REPORTED THE BLACK IMPACTOR WAS CRACKED AFTER IMPLANT IMPACTION. THERE WERE NO COMPLAINTS, DELAYS, OR HARM TO PATIENT. ALL PARTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162028 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGERY THE BASE OF THE IMPACTOR HAD THE PLASTIC TEARING OFF. THERE WERE NO DELAYS AND NOTHING WAS LEFT IN THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072209 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT THE ATTUNE IMPACTOR BROKE. IT WAS NOTED THAT THE DEVICE WAS BEING USED WITH A BROACH HANDLE THAT DID NOT RETAIN WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031520 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT A PIECE OF THE ATTUNE SYSTEM IMPACTOR HANDLE BROKE OFF DURING AN UNSPECIFIED SURGICAL PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028259 ↗
• MalfunctionApr 27, 2026Break; Scratched Material

  IT WAS REPORTED THAT UPON FEMORAL IMPACTION THE PLASTIC ON THE SOLID BLACK HANDLE WAS DAMAGED BEYOND USE. THE PLASTIC HAS BEEN FLAKING OFF, CHIPPED AND SCRATCHED ON THE IMPACTION EDGE, ALL IN ONE PIECE STILL THOUGH. ALL PIECES WERE REMOVED AND THERE WAS NO DAMAGE DONE TO THE PATIENT. I HAVE NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997160 ↗
• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT THE IMPACTOR PLASTIC WAS CHIPPED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909877 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT THE ATTUNE SYSTEM IMPACTOR, ATTUNE FB TIBIAL IMPACTOR, ATTUNE FEMORAL IMPACTOR, AND ATTUNE EVAL BLT NO-SPK SZ 1-10 WERE BROKEN INTRAOPERATIVELY. THE EVENT INVOLVED A BROKEN MODULAR FB AND FEMORAL IMPACTOR, A BROKEN TIBIAL EVALUATION BULLET, AND A UNIVERSAL IMPACTOR. THERE WAS NO PATIENT INVOLVEMENT OR OBSERVABLE CLINICAL SYMPTOMS, AND NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887649 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT, UPON IMPACTION, THE IMPACTION HANDLE WAS HEAVILY DAMAGED AND RENDERED UNUSABLE. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD. THERE WAS NO PATIENT HARM AND NO DELAY TO THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844606 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT THE BLACK ATTUNE SYSTEM UNIVERSAL IMPACTOR WAS CHIPPING DURING USE. NO PATIENT DELAYS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844487 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR HAD A PIECE BREAK OFF IT. IT IS NOT IN THE PATIENT AND DIDN'T DELAY THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820828 ↗
• MalfunctionMar 11, 2026Material Deformation

  IT WAS REPORTED THAT FEMORAL IMPACTOR WAS DEFORMED DUE TO REPEATED USE. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570808 ↗