ATTUNE 1520-20-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295542643), received between Nov 28, 2023 and Aug 3, 2026 — classified as 19 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had a painful Right knee. Resurfaced patella and added thicker poly.DOI: (b)(6), 2024DOR: (b)(6), 2026Affected side: Unknown

  Patient problems: Pain

  MAUDE report 50114441 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: ON (B)(6) 2025. DOR: ON (B)(6) 2026. AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 25782968 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. ALL COMPONENTS WERE REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 25019582 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24742995 ↗
• MalfunctionMar 5, 2026Fracture

  IT WAS REPORTED THAT ANTERIOR LOCKING TAB ON INSERT BROKE OFF WHILE IMPLANTING IT. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24518446 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE SECOND LINER EXCHANGE TO RULE OUT INFECTION. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24210627 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2024. DOR:(B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24189815 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY AND PATIENT DISCOMFORT. NO OTHER INFORMATION WAS KNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 24079143 ↗
• InjuryDec 4, 2025Adverse 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 I&D WITH POLY EXCHANGE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23716743 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON SWAPPED POLY ON THE RIGHT KNEE. 7X5 ATTUNE MS. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23513559 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION FROM CAT SCRATCH. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23290481 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED AND IMPLANTED FOR INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23015150 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT LOST EXTENSION DUE TO LYSIS OF ADHESIONS. THE SURGEON CLEANED THE JOINT AND REPLACED THE POLY. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

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

  MAUDE report 22051329 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SURGEON REMOVED ALL IMPLANTS AND REPLACED WITH NEW. DOI: (B)(6) 2025. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21985942 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO FALL. INSERT EXCHANGED. DOI: UNKNOWN. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 21922340 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 21595047 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF KNEE. DOI: ON (B)(6) 2024, DOR: ON (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20590518 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A VRAS ROBOTIC KNEE DONE ON (B)(6) 2024. PATIENT HAD COMPLAINED OF STIFFNESS AND LACK OF ROM. PATIENT WAS MANIPULATED WHICH WAS UNSUCCESSFUL. DOCTOR REVISED PATIENT'S FEMUR TO HELP WITH ROM. DOWNSIZED FEMUR, REMOVED PATELLA, ADFIXIUM BASEPLATE WAS WELL FIXED (RETAINED). OTHER COMPONENTS WERE REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 20345837 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD KNEE REPLACED ON (B)(6) 2023. SHE HAD SPINE SURGERY ON (B)(6) 2023 AND WAS AN INPATIENT. PT WAS WORKING WITH PATIENT WHEN PATIENT FELL DOWN AND BROKE DISTAL FEMUR. DOCTOR WAS DOING THE ORIF AND REQUESTED A NEW POLY TO PUT ON TIBIA. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 18769546 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS A STIFF KNEE. SURGEON REVISED AN ATTUNE MS TO A CRS. CASE WENT WELL. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 18220866 ↗