ATTUNE 1517-10-516Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295055952), received between May 3, 2019 and Jul 27, 2026 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient was revised with washout due to infection.DOI: Unknown.DOR: (b)(6) 2026.Affected Side: Right Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50024610 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME UNSTABLE SO DOCTOR SWITCHED THEIR POLY TO A THICKER POLY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 23805233 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POLY SWAP FOR INFECTION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22384475 ↗
• InjuryMay 30, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY SWAP FOR MORE STABILITY, WORN OUT POLY INSERT (REVISION CRS ROTATING PLATFORM). AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22113502 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. I&D W POLY EXCHANGE WAS PERFORMED. THERE WERE NO BROKEN INSTRUMENTS AND NO ADVERSE EVENTS WERE REPORTED. THERE WERE NO DELAYS. DOI: (B)(6), 2021. DOR: (B)(6), 2025 AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21971413 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO SURGICAL DELAYS.

  Patient problems: Pain

  MAUDE report 20149424 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AND INSTABILITY. THE SURGEON PLACED A THICKER INSERT AND INSTABILITY WAS ADDRESSED. NO PATIENT HARM OCCURRED. THE IMPLANTS WERE WELL FIXED AND WELL ALIGNED. THE SIZES APPEARED APPROPRIATE, POSTERIOR OFFSET APPEARED TO BE APPROPRIATE AS WELL AS THE JOINT LINE. THE JOINT LINE DID SHIFT SLIGHTLY WITH THE THICKER INSERT, BUT THE PATELLA STILL TRACKS REASONABLY WELL WITH IMPINGEMENT TO BE MINIMAL UNTIL DEEPER FLEXION RANGES. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2022 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17735755 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE A KNOWN INFECTION - I&D WITH POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16627646 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS AN INFECTED KNEE. POLY EXCHANGED. NO LOOSENING AND NO SURGICAL DELAY REPORTED. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9834903 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD ALL IMPLANTS REMOVED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9443920 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGE WAS DONE. DOI: (B)(6) 2019 DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8653507 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF RECURRING INFECTION. THE DOCTORS BELIEVED THE INFECTION HAD BEEN ERADICATED AND WENT AHEAD WITH THE REIMPLANTATION. AFTER MULTIPLE WASHOUTS AND WOUND VAC CHANGES, SURGEON HAD TO REMOVE IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8578790 ↗