ATTUNE 1517-10-906Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295056348), received between Oct 28, 2022 and Sep 30, 2026 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to poly swap and washout performed for potential infection. No additional information available.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50945390 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS KNEE PAIN AND THE POLY SWAPPED TO THICKER INSERT. AFFECTED AREA: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21873633 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF ATTUNE REVISION FEMORAL COMPONENT, INCLUDING SLEEVE AND STEM FOR STIFFNESS. PATIENT UNDERWENT REVISION ATTUNE APPROX 3 YEARS AGO (EXACT DATE UNKNOWN). PRESENTED WITH STIFFNESS, FIXED FLEXION AT 25-30 DEGREES. FEMORAL COMPONENTS REMOVED AND SROM ROTATING PLATFORM HINGE FEMORAL COMPONENT WITH ATTUNE CROSS OVER BEARING INSERTED. SURGEON ABLE TO GET FULL EXTENSION ON THE TABLE. TIBIAL COMPONENTS NOT REVISED. TRYING TO SOURCE COMPONENT SIZES AND LOT NUMBERS FROM CUSTOMER SERVICES. IF OTHER, DESCRIBE : REVISION OF ATTUNE REVISION FEMORAL COMPONENT TO SROM HINGE., WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES , PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC? NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO, IS THE PATIENT PART OF A CLINICAL STUDY : NO, (B)(4). DEVICE PROPERTY OF :NONE, DEVICE IN POSSESSION OF :NONE, (B)(4). DEVICE PROPERTY OF :NONE, DEVI

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 17058285 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15693285 ↗