ATTUNE 1517-10-306Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295055686), received between Sep 28, 2021 and Sep 26, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Unintended Movement” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION AND REMOVED POLY AND WENT UP IN SIZE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 20311466 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH A POLY ATTUNE REVISION. DOI: FEB 23, 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17855057 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSERT NEEDED BIGGER SIZE DUE TO UNKNOWN REASON. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17512728 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP WAS PERFORMED FOR INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15942592 ↗
• InjuryAug 11, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE ATTUNE FOR THE OSTEOARTHRITIS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. APPROXIMATELY ONE MONTH AFTER THE SURGERY, THE PATIENT COMPLAINED THAT THE AFFECTED AREA FELT STRANGE. THE X RAY SHOWED THAT IT SEEMED THAT SPIN OUT OCCURRED. A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2022. THE INSERT WILL BE REPLACED. ACCORDING TO THE SURGEON, THE IMPLANTS MIGHT HAVE BEEN LOOSENED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 15210244 ↗
• InjurySep 28, 2021Fracture; Unintended Movement; Fracture; Unintended Movement

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS FELL AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. PATIENT FELL MORE THAN ONCE ON OPERATIVE KNEE FRACTURING THE PATELLA. WHEN KNEE WAS EXPOSED IN SURGERY THE CONSTRAINED TIBIAL INSERT (SIZE 3 6MM) WAS 180 DEGREES BACKWARDS. THE POST HAD A SIGNIFICANT PIECE SHEERED OFF. IT APPEARS AND IN THE SURGEON'S BEST JUDGEMENT, THAT THE FALL CREATED ENOUGH FLEXION LAXITY THAT THE POLY SPUN 180 DEGREES AND RELOCATED ITSELF. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 12539818 ↗