ATTUNE 1517-10-518Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295055969), received between Aug 10, 2020 and Sep 24, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the poly swap for possible infection.DOI: (b)(6) 2025.DOR: (b)(6)2026.Affected side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50887094 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE REMOVAL OF IMPLANTS FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24327413 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSSIBLE INFECTION OF REVISION RTKA THAT WAS IMPLANTED (B)(6) 2024. REMOVED ALL IMPLANTS AND WASHED OUT AND PERFORMED A 1 1/2. STAGE REVISION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24054803 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INFECTION & PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 18977627 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INSTABILITY IN FLEXION. DOCTOR DECIDED THAT WE WERE NOT GOING TO BE ABLE TO MAKE A CRS INSERT WORK WITH JUST BALANCING. HE DECIDED A HINGED KNEE WAS NECESSARY. WHILE REMOVING THE ATTUNE SLEEVE HE ENCOUNTERED MORE BONE LOSS THAN HE HOPED AND DECIDED THAT A DISTAL FEMORAL REPLACEMENT WAS NECESSARY. HE WOULD HAVE LIKED TO BE ABLE TO PUT A HINGED KNEE INTO THE ATTUNE REV SLEEVE. DOI: (B)(6) 2020. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16203363 ↗
• InjuryNov 8, 2022Naturally Worn; Naturally Worn

  PATELLA LOSENING, CHANGE INSERT 18MM BEGINING OF WEAR LATERAL ATTUNE REVISION RIGHT. 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)(6). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(6). 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: Insufficient Information

  MAUDE report 15751618 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE REVISION FIRST IMPLANTATION (B)(6) 2022. INFECTION . CHANGE MOBILE PARTS. DOI: (B)(6) 2022; DOR: (B)(6) 2022; RIGHT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 14021408 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. COMPONENTS WERE EXPLANTED AND A STATIC ANTIBIOTIC SPACER WAS PLACED IN HOPE TO CLEAR INFECTION. NO LOOSENING REPORTED. NO DELAY TO SURGERY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE. THIS COMPLAINT CAPTURES THE 11TH AND 12TH IMPACTED PRODUCT OF MAIN COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11570751 ↗
• InjuryAug 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. SURGEON IMPLANTED A THICKER INSERT. DOI: UNKNOWN. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10385714 ↗