ATTUNE 1516-30-305Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295047506), received between May 1, 2018 and Feb 10, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF PAIN IN THE LEFT TIBIA. TIBIA INSERT WAS CHANGED AND PATELLA WAS RESURFACED.

  Patient problems: Pain

  MAUDE report 21344912 ↗
• InjuryMar 20, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S POLY WAS SPUN OUT, A THICKER POLY WAS PLACED. NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18940045 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT NO INFECTION AND SURGICAL DELAYS WERE REPORTED. THE UNK ATTUNE KNEE PATELLA RESURFACED.

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

  MAUDE report 17804682 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF RIGHT ATTUNE TKR PATIENT EXPERIENCING PAIN, SURGEON SUSPECTED TIBIAL BASEPLATE LOOSENING, POTENTIAL EVIDENCE ON SCANS. UPON OPENING TIBIAL COMPONENT WAS NOT LOOSE. SURGEON CHOSE TO REMOVE TIBIAL COMPONENT AND PUT IN REVISION TIBIA WITH SLEEVE AND INCREASE SIZE OF POLY. FEMORAL COMPONENT AND PATELLA COMPONENT UNTOUCHED. DOI: (B)(6) 2019. DOE: (B)(6) 2023.

  Patient problems: Pain

  MAUDE report 17170143 ↗
• InjurySep 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6), 2020 , DOR: (B)(6), 2021 , RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12546306 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER KNEE REPLACED RECENTLY AND DID NOT ACHIEVE A FULL RANGE OF MOTION AND HAD SOME FIBROSIS AROUND THE KNEE. THE SURGEON DID A POLY CHANGE WHERE THE INSERT WAS SWAPPED OUT WITH A NEW SZ 3X5MM ATTUNE CR INSERT. THE FEMORAL, TIBIAL, AND PATELLAR COMPONENTS WERE LEFT IN SITU. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 12129084 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE CARDIOPULMONARY ARREST AFTER AN HOUR FROM TKA SURGERY ON (B)(6) 2018. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, AND NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL SUCH AS DISEASE NAME, CAUSAL RELATIONSHIP, OR RECENT PATIENT¿S CONDITIONS.

  Patient problems: Cardiac Arrest; Not Applicable

  MAUDE report 7475112 ↗