ATTUNE 1520-20-808Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295542759), received between Dec 5, 2024 and May 1, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR ARTHROFIBROSIS. SCAR TISSUE DEBRIDEMENT PERFORMED AND DOWNSIZED POLY. NO LOOSENING, NO SURGICAL DELAY, NOTHING OTHER TO REPORT. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Adhesion(s); Arthrofibrosis

  MAUDE report 25058158 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. THE EVENT DID NOT HAPPEN IN SURGERY. THE IMPACTED PRODUCT WAS AN 8X8 RIGHT MS POLY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24758458 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY EXCHANGE FOR INSTABILITY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24316092 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED: NO INFORMATION PROVIDED. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: NO INFORMATION PROVIDED. DEPUY SYNTHES PRODUCTS USED: NO INFORMATION PROVIDED CATALOG NUMBER: NO INFORMATION PROVIDED. LOT NUMBER: NO INFORMATION PROVIDED. COMPONENT TYPE: NO INFORMATION PROVIDED. DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 23742655 ↗
• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PATIENT'S PRIMARY KNEE WAS REVISED DUE TO INSTABILITY. DURING THE REVISION PROCEDURE, HIS PRIMARY 8MM ATTUNE FB MS INSERT WAS REMOVED AND REPLACED BY A THICKER 12MM ATTUNE FB MS INSERT, WHICH TIGHTENED HIS FLEXION AND EXTENSION GAPS. DEPUY SYNTHES SMARTSET CEMENT WAS USED DURING THE PATIENT'S PRIMARY PROCEDURE TO CEMENT ONLY THE PATELLA COMPONENT. THE LOT NUMBER FOR THE CEMENT USED IS UNKNOWN SINCE IT WAS HOSPITAL OWNED AND ORDERED DIRECTLY FROM DEPUY SYNTHES. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22952387 ↗
• MalfunctionAug 22, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DOCTOR INSERTED THE POLY AND IT WOULD NOT SEAT PROPERLY ON THE MEDIAL SIDE. HE REMOVED THE POLY AND TRIED TO RE-INSERT IT WITH THE SAME RESULT. THEN HE CHANGED THE POLY AND IT SEATED PROPERLY. DOE: (B)(6), 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873324 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22688271 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN . DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22308863 ↗
• InjuryDec 5, 2024Adverse 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 REPORTED.

  Patient problems: Pain

  MAUDE report 20853118 ↗