ATTUNE 1518-20-505Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295541646), received between Nov 8, 2022 and Jul 29, 2026 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Improper or Incorrect Procedure or Method

  It was reported that an incorrect implant was implanted during Attune VELYS case. The left tibial insert was implanted instead of the intended right tibial insert. The patient required a corrective invasive procedure to remove the incorrect insert and replace it with the correct one.

  Patient problems: Insufficient Information

  MAUDE report 50074079 ↗
• InjuryJul 29, 2026Improper or Incorrect Procedure or Method

  It was reported that two inserts were involved in an event in which the left insert was incorrectly implanted on the right side and was identified after surgery. The patient required a return to surgery for removal of the incorrect insert and implantation of the correct right insert, with reopening of the incision and exchange of the inserts. The outcome was reported as a good result, with the patient back on the standard recovery path. The left insert was discarded after removal, and the right insert remained implanted.

  Patient problems: Insufficient Information

  MAUDE report 50072923 ↗
• InjuryJul 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED INFECTION. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 25903688 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25348589 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP WAS PERFORMED DUE TO SURGEON SUSPICION OF INSTABILITY. A 5MM POLY WAS REMOVED AND REPLACED WITH A 7MM POLY. NO OTHER INFORMATION WAS KNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25017712 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A RETICULAR REPAIR THICKER POLY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24913531 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SURGEON SUSPICION OF INFECTION. NO OTHER INFORMATION IS KNOWN. DOI-(B)(6) 2024. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24691279 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN. THE PATELLA HAD NOT YET BEEN RESURFACED; DURING THE REVISION PROCEDURE, THE PATELLA WAS RESURFACED, EXCISED SCAN, RELEASED PCL AND SWAPPED POLY FOR SAME SIZE. DOI: (B)(6) 2024, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 24469012 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS WASHOUT WITH POLY EXCHANGE DUE TO INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24052632 ↗
• MalfunctionDec 8, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT TKA SURGERY ON KNEE WITH THE PRODUCT IN QUESTION. THE INSERT DID NOT GO IN PROPERLY WHEN IT WAS HAMMERED IN, SO IT WAS REMOVED USING THE ELEVATORIUM AND DEFORMATION OF THE PRODUCT IN QUESTION WAS CONFIRMED WHEN IT WAS HAMMERED IN AGAIN. IT IS POSSIBLE THAT THE INSERT WAS HAMMERED IN AT A SLIGHTLY DIFFERENT ANGLE THE FIRST TIME, BUT IT IS NOT CLEAR WHETHER THE DEFORMATION OCCURRED WHEN THE INSERT WAS HAMMERED IN OR REMOVED. SINCE DEFORMATION WAS CONFIRMED, IT WAS NOT USED AND ANOTHER INSERT WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 23747206 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND OPENED INCISION WHICH REQUIRED AN IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 23703965 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. CAN YOU PLEASE CONFIRM WHETHER THE INFECTION WAS ACTUALLY PRESENT OR JUST SUSPECTED? IT WAS JUST SUSPECTED ACCORDING TO THE INFORMATION I WAS GIVEN.

  Patient problems: Unspecified Infection

  MAUDE report 23692821 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND OPENED INCISION FROM PRIOR KNEE REPLACEMENT. DOI: (B)(6) 2025. DOR: (B)(6), 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 22440213 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AFTER TOTAL KNEE REPLACEMENT AND RIPPED PART OF RETICULAR REPAIR. THE SURGEON WANTED TO EXCHANGE POLY WHILE REPAIRING. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 21944254 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A LEFT KNEE REVISION SURGERY ON (B)(6) 2024 DUE TO INFECTION. THE POLY WAS EXCHANGED. THE ORIGINAL DATE OF IMPLANT WAS (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20352917 ↗
• MalfunctionJun 4, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE MEDIAL STABILIZED INSERT HAD DEBRIS ON THE INSIDE OF THE PACKAGING. NO DEBRIS ON THE ACTUAL IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19457602 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE, SCHEDULED FOR I&D WITH POLY EXCHANGE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15752306 ↗