ATTUNE 1520-20-706Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295542650), received between Oct 10, 2023 and Jul 31, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Fracture

  It was reported that during a Total Knee Replacement (TKR) surgical procedure of the right knee it was observed that the Attune Insert broke during Implantation. There was no surgical delay and no harm to the patient. All available information has been disclosed. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096958 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATUNE CR RT MS INS SZ 7 6, WAS REPORTED INVOLVING INABILITY TO ACHIEVE FULL EXTENSION. DOI: (B)(6) 2026, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 25035027 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24567388 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. ANTIBIOTIC SPACER WAS PLACED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24530515 ↗
• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER EXCHANGE AND WASH OUT WAS PERFORMED TO RULE OUT INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24183898 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE REASON FOR REVISION? WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS/CONSEQUENCE THAT LED TO THE REVISION SURGERY? -THE PATIENT HAD LAXITY IN THE KNEE, THEREFORE UPSIZE POLY. B .WAS THERE ANY ALLEGED DEFICIENCY TO THE EXPLANTED DEVICE? IF YES, PLEASE PROVIDE DETAILS. -NO. C . WHAT WAS THE EXACT ALLEGATION ? -LAXITY IN THE KNEE.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 23896778 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FLEXED KNEE TOO FAR AND TORE RETINACULUM. SURGEON REPAIRED AND WHILE DOING SO WANTED TO EXCHANGE POLYETHYLENE LINER. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23037423 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS UNSTABLE AND SURGEON DECIDED TO EXPLANT AND REVISE ALL COMPONENTS. THERE WAS NO DELAY OR COMPLAINTS. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22579752 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND HAD WOUND DEHISCENCE. KNEE WAS WASHED OUT AND POLY WAS SWAPPED FOR SAME SIZE NEW POLY. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 22044958 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INSTABILITY WENT UP LINER SIZE. DOR: UNKNOWN AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21221042 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOE: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 20905886 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : THERE WAS NO UNKNOWN PATELLA. SURGEON RESURFACED PATIENT'S NATIVE PATELLA.

  Patient problems: Discomfort

  MAUDE report 20613289 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT AND I+D WASHOUT WITH POLY EXCHANGE. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION. DOI- (B)(6) 2023. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18425211 ↗
• InjuryOct 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AT RIGHT MS POLY WAS IMPLANTED INTO A LEFT KNEE WHEN PATIENT WAS IN THE RECOVERY ROOM. THE PATIENT WAS BROUGHT BACK INTO THE OR AND POLY WAS EXCHANGED FOR THE APPROPRIATE SIZE LEFT MS POLY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17903825 ↗