ATTUNE 1518-20-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295541806), received between Apr 6, 2023 and Apr 28, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED ARTHROFIBROSIS, RESULTING IN A LOSS OF RANGE OF MOTION. DOCTOR PERFORMED A PROCEDURE TO REMOVE THE FIBROTIC TISSUE, WHICH RESOLVED THE ISSUE. DURING THE PROCEDURE, HE ALSO ELECTED TO REPLACE THE POLYETHYLENE COMPONENT. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 25018902 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24413544 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LTKA ON (B)(6) 2025. PATIENT CAME INTO THE ER ON (B)(6) 2025 WITH SEVERE PAIN & AN INFECTION. DR DECIDED THE BEST COURSE OF TREATMENT WAS TO DO A WASHOUT WITH A POLY EXCHANGE. DOI: (B)(6) 2025, DOR: (B)(6) 2025; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24037571 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE POLYETHYLENE INSERT WAS EXCHANGED FOR A CLEAN NEW POLY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23920910 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND OPENED THE INCISION POST-OP. DOCTOR OPENED AND WASHED OUT THE JOINT AND SWAPPED THE POLY. THERE WAS NO PATIENT INJURY OR DELAY. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 23051800 ↗
• MalfunctionMay 2, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE SURGEON QUESTIONED STERILITY DUE TO WAY PACKAGING CAME SEPARATED. NO EFFECT ON PATIENT AS THE IMPLANT DID NOT ENTER STERILE FIELD. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953954 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19712316 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON RECEIVED:A. WAS THERE ANY SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS THAT LED TO THE WASHOUT? THE PATIENT WAS EXPERIENCING THIGH PAIN.

  Patient problems: Pain

  MAUDE report 18694759 ↗
• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALL AND OPENED WOUND. SURGEON WASHED OUT KNEE AND REPLACED POLY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 16689680 ↗