ATTUNE 2544-91-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295443803), received between Jan 22, 2021 and Apr 22, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION AND THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953278 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT UPON INSPECTION, SETS WERE BROKEN. HOSPITALS HAVE COMPLAINED ABOUT BROKEN INSERTS/PANS AND FLAGGED FOR STERILIZATION. DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24666425 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A RIGHT SIDE VELYS RAS TOTAL KNEE REPLACEMENT, THE ALL POLY TIBIA (APT) IMPACTOR BROKE WHILST SEATING THE DEFINITIVE CEMENTED ALL POLY TIBIAL COMPONENT. THE TWO PLASTIC ¿FEET¿ BROKE OFF THE INSERTER DURING THE FINAL IMPACTION. ALL FRAGMENTS WERE RETRIEVED, THERE WAS NO DELAY TO SURGERY, NO IMPACT TO PATIENT. NO FURTHER ACTION WAS REQUIRED AS THE TIBIAL COMPONENT WAS SUFFICIENTLY SEATED AT THIS POINT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728781 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT THE TWO (2) TABS ON THE ALL POLY IMPACTOR BROKE OFF. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21754062 ↗
• MalfunctionSep 15, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE INSTRUMENT BROKE INTO 2 PIECES. ALL PIECES WERE RETRIEVED FROM THE SURGICAL FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17757147 ↗
• MalfunctionApr 25, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807089 ↗
• MalfunctionApr 14, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THE INSTRUMENTS WERE DAMAGED, BROKEN, CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744592 ↗
• MalfunctionApr 4, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE HOSPITAL'S STERILE PROCESSING DEPARTMENTS REMOVED THE DAMAGED INSTRUMENTS FROM USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673632 ↗
• MalfunctionMar 14, 2023Break; Break

  IT WAS REPORTED THAT THE SMALL ANTERIOR PART OF ALL POLY IMPACTOR BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16538785 ↗
• MalfunctionFeb 6, 2023Break; Break

  IT WAS REPORTED THAT THE POLY IMPACTOR HANDLE BROKE DURING SURGERY. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16306255 ↗
• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT THE IMPACTOR IS CHIPPED ON THE END AND NEED REPLACING. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624824 ↗
• MalfunctionSep 26, 2022Break; Break

  IT WAS REPORTED THAT THE AP 6-8 IMPACTOR WAS BROKEN. ONE OF THE ANTERIOR FEET WAS BROKEN OFF. ALL PIECES WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15487169 ↗
• MalfunctionAug 23, 2022Break; Break

  IT WAS REPORTED THAT THE END OF THE ALL POLY IMPACTOR IS BROKEN AND NEEDS REPLACING. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277827 ↗
• MalfunctionJun 16, 2022Break; Break

  IT WAS REPORTED THAT PRONGS ON IMPACTOR BROKE OFF DURING IMPACTION. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713089 ↗
• MalfunctionFeb 8, 2022Break; Break

  IT WAS REPORTED THAT THE ALL POLY ATTUNE PS WAS IMPACTING. THE FRONT PART OF THE IMPACTOR BROKE OFF. THIS IS THE 2ND IMPACTOR TO BREAK OFF. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481009 ↗
• MalfunctionFeb 8, 2022Break; Break

  IT WAS REPORTED THAT THE ALL POLY ATTUNE PS WAS IMPACTING. THE FRONT PART OF THE IMPACTOR BROKE OFF. THIS IS THE 2ND IMPACTOR TO BREAK OFF. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481008 ↗
• MalfunctionDec 9, 2021Break; Break

  IT WAS REPORTED THAT THE IMPACTOR WAS USED TO IMPACT THE ALL POLY TIBIA. AS THE TIBIA WAS BEING IMPACTED, BOTH OF THE ANTERIOR TABS OF THE IMPACTOR BROKE. THE BROKEN PIECES WERE FOUND AND ACCOUNTED FOR AND A DIFFERENT IMPACTOR WAS USED TO FINISH WITH THE IMPACTION OF THE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED 03 DEC 2021 AT 8:10 PM STATING - WITH REGARDS TO THIS, PLEASE CONFIRM IF ANY OF THE FOLLOWING INFORMATION IS AVAILABLE: DID IT BREAK INTO 2 OR MORE PIECES? IT BROKE INTO TWO PIECES. BOTH ANTERIOR TABS BROKE. PLEASE PROVIDE VALID LOT NUMBER FOR ATTUNE APT IMPACTOR SZ 6-8, (254491003). (B)(4) OR (10)AZ314333. PLEASE VERIFY IF THE PRODUCT IS AVAILABLE FOR RETURN OR NOT? THE PRODUCT IS AVAILABLE TO SHIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968331 ↗
• MalfunctionDec 3, 2021Break; Break

  IT WAS REPORTED THAT THE POLY TIBIAL IMPACTOR BROKE. ALL PIECES WERE RECEIVED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12922972 ↗
• MalfunctionJul 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ONE OF THE SURGEONS SAID THAT WE NEED TO DO SOMETHING ABOUT OUR ATTUNE ALL POLY IMPACTORS. HE STATED THAT THERE NEEDS TO BE A COLOR CHANGE AS THE WHITE COLOR OF THE IMPACTOR WAS TOO CLOSE IN COLOR TO THE BONE CEMENT AND THAT THE TINY CEMENT FLECKS ARE BEING MISSED IN STERILE PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247826 ↗
• MalfunctionJul 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE CEMENT FRAGMENTS REMAIN ON WHILE IMPACTING AND CANNOT BE SEEN. IT WAS ALSO REPORTED A DIFFERENT COLOR IS NEEDED TO SEE RESIDUAL CEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204812 ↗
• MalfunctionApr 26, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE IMPACTOR WAS SCUFFED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725401 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT THE ATTUNE ALL POLY IMPACTOR 6-8 BROKE WHILE IMPACTING ALL POLY TIBIA IMPLANT. THE TWO WHITE ANTERIOR GUIDES FELL TO THE FLOOR. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615648 ↗
• MalfunctionJan 22, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE IMPACTOR BROKE INTO EXACTLY 2 PIECES. ONE OF THE TWO PLASTIC TABS THAT HANG ANTERIOR OFF TIBIA BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217513 ↗