ATTUNE 2545-00-704Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295133766), received between Aug 3, 2017 and May 13, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE WOULD NOT FULLY LOCK WHEN UNDER TENSION ONCE LOCKED, IT DID NOT ADJUST WHILE UNDER DETENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164919 ↗
• MalfunctionApr 21, 2026Scratched Material

  IT WAS REPORTED THAT A 4 RIGHT CR FEMORAL TRIAL HAS HEAVY DEEP SCARRING MAKING IT A STERILITY CONCERN. EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940431 ↗
• MalfunctionFeb 26, 2026Break

  ADDITIONAL INFORMATION RECEIVED: A. DID THE DEVICE BREAK INTO TWO OR MORE PIECES? IS IT BENT, CRACKED, STRIPPED, SCRATCHED, WORN, OR CROSS THREADED? PLEASE EXPLAIN. NO BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456915 ↗
• MalfunctionFeb 26, 2026Break

  ADDITIONAL INFORMATION RECEIVED: A. DID THE DEVICE BREAK INTO TWO OR MORE PIECES? IS IT BENT, CRACKED, STRIPPED, SCRATCHED, WORN, OR CROSS THREADED? PLEASE EXPLAIN. - NO BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456901 ↗
• 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 23831465 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT THE SIZE 4 RIGHT CR FEMUR TRIAL CRACKED DURING THE CASE. THE PIECES WERE EASILY REMOVED AND THE CASE PROCEEDED WITHOUT COMPLICATION. SURGERY WAS DELAYED BY ONE MINUTE. THE SURGEON TRIALED WITH THE OPPOSITE SIDE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059510 ↗
• MalfunctionNov 8, 2024Crack; Crack

  IT WAS REPORTED ON (B)(6) 2024 THAT TRIAL WAS CRACKED.

  Patient problems: Insufficient Information

  MAUDE report 20646318 ↗
• MalfunctionJun 25, 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 19609417 ↗
• MalfunctionApr 24, 2024Break; Crack; Break; Crack

  AT A GENERAL CHECK OF THE FEMORAL TRIAL CRACKS WERE DISCOVERED IN THE SULCUS PART OF THE CS FEMORAL TRIALS AND CRACKS ON THE ANTERIOR SIDE OF THE BOX IN HET PS FEMORAL TRIALS. THE CRACKS CAN BE SEEN BY PUTTING TENSION ON THE TRIALS. AFTER INSPECTION WITH STRESS TEST ONE FEMORAL TRIAL BROKE IN TWO. THERE WERE NO IMPLICATIONS DURING ANY SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171645 ↗
• MalfunctionApr 24, 2024Break; Crack; Break; Crack

  AT A GENERAL CHECK OF THE FEMORAL TRIAL CRACKS WERE DISCOVERED IN THE SULCUS PART OF THE CS FEMORAL TRIALS AND CRACKS ON THE ANTERIOR SIDE OF THE BOX IN HET PS FEMORAL TRIALS. THE CRACKS CAN BE SEEN BY PUTTING TENSION ON THE TRIALS. AFTER INSPECTION WITH STRESS TEST ONE FEMORAL TRIAL BROKE IN TWO. THERE WERE NO IMPLICATIONS DURING ANY SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171628 ↗
• MalfunctionJan 16, 2024Scratched Material; Illegible Information; Scratched Material; Illegible Information

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DAMAGE WAS NOTICED DURING CLEANING SO POST-SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519244 ↗
• MalfunctionNov 27, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE PAINT ON THE FEMUR TRIALS IS CHIPPING. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209832 ↗
• MalfunctionNov 22, 2023Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191733 ↗
• MalfunctionNov 15, 2023Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT THE TRIAL IS WORN AND BROKEN. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES , 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. (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 18145646 ↗
• MalfunctionNov 14, 2023Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT THE INSTRUMENTS WERE REJECTED FOR SCRATCH/DENTS. THEY WERE CONSIDERED UNACCEPTABLE BY THE STERILE PROCESSING DEPARTMENT. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18135017 ↗
• MalfunctionJun 5, 2023Break; Break

  IT WAS REPORTED THAT THE ATTUNE CR FEMORAL TRIAL SPLIT INTO TWO PIECES WHEN IT WAS IMPACTED INTO PLACE. THIS OCCURRED DURING THE FINAL TRAILING, SO ABLE TO CONTINUE WITHOUT HOLDING UP THE PROGRESS OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061188 ↗
• MalfunctionApr 27, 2023Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

  IT WAS REPORTED THAT THE SPD DEPARTMENT FEMUR TRIALS HAVE SCRATCHES AND INDENTIONS THAT MAKE THEM IMPOSSIBLE TO CLEAN. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824585 ↗
• MalfunctionApr 20, 2023Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS ARE CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777645 ↗
• MalfunctionMar 31, 2023Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE IMPACTORS AND FEMORAL TRIALS ARE CRACKED/CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657426 ↗
• MalfunctionAug 22, 2022Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE TRIALS ARE BROKEN DUE TO WEAR AND TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266232 ↗
• MalfunctionJan 18, 2022Material Integrity Problem; Material Integrity Problem

  I WAS INFORMED TODAY, MONDAY 25TH OCTOBER 2021 OF THE FOLLOWING DAMAGED INSTRUMENT AT SWLEOC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13279154 ↗
• MalfunctionNov 9, 2021Break; Break

  IT WAS REPORTED THAT THE FOLLOWING INSTRUMENT WAS BROKEN: 254 500704. - 1 X ATTUNE CR FEM TRIAL SZ 4 RT, NO FURTHER INFORMATION IS AVAILABLE AT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779058 ↗
• MalfunctionOct 8, 2021Naturally Worn; Naturally Worn

  SEE ATTACHED WORD DOC FOR PRODUCT NUMBERS. IT WAS REPORTED THAT ALL OF THESE INSTRUMENTS ARE WORN OUT BEYOND SURGICAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599249 ↗
• MalfunctionNov 23, 2020Material Twisted/Bent; Material Twisted/Bent

  WORN INSTRUMENTS IDENTIFIED BY STERILISATION , DID NOT OCCUR DURING SURGERY SO NO SURGEON WAS INVOLVED. THIS HAS BEEN REPORTED BY ONE OF THE HEALTHCARE WORKERS AT THE HOSPITAL WHO IS THE CONTACT IN THIS FORM. INSTRUMENTS TAGGED AS DAMAGED AND BEING RETURNED TO WA OPERATIONS VIA COURIER. THIS IS A CONSIGNMENT SET, SET NUMBER TRAY SERIAL / BATCH NUMBER IS UNKNOWN. OPERATIONS PLEASE REFER TO THE WA ONE DRIVE COMPLAINT DATABASE FOR FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10886219 ↗
• MalfunctionOct 27, 2020Naturally Worn; Naturally Worn

  WORN INSTRUMENTS IDENTIFIED BY STERILIZATION , DID NOT OCCUR DURING SURGERY SO NO SURGEON WAS INVOLVED. THIS HAS BEEN REPORTED BY ONE OF THE HEALTHCARE WORKERS AT THE HOSPITAL WHO IS THE CONTACT IN THIS FORM. INSTRUMENTS TAGGED AS DAMAGED AND BEING RETURNED TO WA OPERATIONS VIA COURIER. THIS IS A CONSIGNMENT SET, SET NUMBER TRAY SERIAL / BATCH NUMBER IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10742161 ↗