ATTUNE 2545-00-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10603295133773), received between Jul 25, 2017 and Aug 18, 2026 — classified as 1 injury, 84 malfunctions.

The most frequently reported specific device problem is “Break” (48 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 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Break

  It was reported that femur trial broke into two pieces. All pieces were retained. The event did not happen in surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50303301 ↗
• MalfunctionAug 17, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50277909 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT FEMUR TRAIL BROKE AS DOCTOR WAS REMOVING THE TRIAL. ALL PRODUCTS WERE RETURNED AND THE CASE CONTINUED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184226 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE CR FEMORAL TRIAL NARROW NOTCH GUIDE WAS PEELING/FLAKING AND WAS BROKEN ON THE TIP. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031281 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT TRIAL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754144 ↗
• MalfunctionMar 3, 2026Break

  BROKEN ATTUNE CR FEM TRIAL SZ 5 RT. 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, IP-02671924. 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 24498114 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT DURING CLEANING AND STERILIZATION PROCESSES IT WAS OBSERVED THAT DEVICES EXHIBIT DAMAGE AND WEAR IN THE CONDYLE AREA. IN ADDITION CHIPS AND SCRATCHES ARE ALSO VISIBLE IN THE DEVICE PHOTOS PROVIDED. THERE WAS NO PATIENT INVOLVEMENT AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456892 ↗
• MalfunctionFeb 19, 2026Break

  DEVICE WAS DAMAGED DURING IMPACTION. THE FRONT WAS CHIPPED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393836 ↗
• MalfunctionFeb 8, 2026Corroded

  IT WAS REPORTED THAT THE INSTRUMENT PITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288240 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT FEMORAL TRIAL FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24031981 ↗
• MalfunctionJan 7, 2026Break

  BROKE 2 FEMORAL SZ5 RIGHT TRIALS WHEN PLACING THE FEMORAL COMPONENT. 2 REPLACEMENTS ARE REQUIRED TO BE SENT IN TO [HOSPITAL]. 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. 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 23994245 ↗
• MalfunctionJan 7, 2026Break

  BROKE 2 FEMORAL SZ5 RIGHT TRIALS WHEN PLACING THE FEMORAL COMPONENT. 2 REPLACEMENTS ARE REQUIRED TO BE SENT IN TO [HOSPITAL]. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993981 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT TRIAL WAS CUT WITH SAW WHILE CUTTING THE PATELLA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831466 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT THE SZ 5 CR ATTUNE FEMORAL TRIAL BROKE, AND THE GENERATED FRAGMENTS WERE SUCCESSFULLY REMOVED. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A NEW TRAY WAS OPENED TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617959 ↗
• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT THE POSTERIOR CONDYLE PART OF THE TRIAL DEVICE BROKE OFF WHEN THE TRIAL WAS IMPACTED ONTO THE PATIENTS FEMUR. IT WAS REPORTED THAT ANOTHER SET WAS OPENED. THERE WERE NO PATIENT CONSEQUENCES DUE TO THE EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS PROLONGED BY THREE MINUTES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544183 ↗
• MalfunctionApr 17, 2025Peeled/Delaminated; Scratched Material; Peeled/Delaminated; Scratched Material

  IT WAS REPORTED THAT THE TRIALS GOUGED/FLAKING.

  Patient problems: Insufficient Information

  MAUDE report 21857322 ↗
• MalfunctionApr 1, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE DEVICE CRACKED DURING A PROCEDURE. NO SURGICAL DELAY. NO PATIENT CONSEQUENCES. PROCEDURE WAS ABLE TO BE COMPLETED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738097 ↗
• MalfunctionMar 20, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THERE WAS DISCOLORATION/(METAL) ABRASION OF THE TRIALS. THE ISSUE WAS SEEN IN CSSD. THERE WAS NO PATIENT INVOLVEMENT AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21654824 ↗
• MalfunctionAug 21, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ADVERSE CONSEQUENCES TO PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013613 ↗
• MalfunctionJun 27, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE TRIALS ALL HAVE SCRATCHES AND KNICKS OUT THE PLASTIC. HOSPITAL WILL NOT ALLOW THEM TO BE USED IN CASES. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629702 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT THE KNEE TRIALS WERE DAMAGED. IT WAS UNABLE TO USE. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458106 ↗
• MalfunctionApr 22, 2024Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  IT WAS REPORTED THAT THE FEMORAL TRIALS WERE WORN AND FLAKING. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19155884 ↗
• MalfunctionMar 26, 2024Break; Break

  IT WAS REPORTED THAT DEVICE WAS DAMAGED. NO PATIENT HARM, DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979412 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT DEVICE BROKE WHILE TRAILING. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18606373 ↗
• MalfunctionJan 17, 2024Break; Break

  CR FEMORAL TRIAL BROKE UPON IMPACTION. NO DELAYS OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524902 ↗