ATTUNE 1518-20-406Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295541578), received between Jun 25, 2025 and Apr 14, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT REVISED DUE TO INFECTION. STAGE 1 OF 2 KNEE REVISION WAS PERFORMED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24874499 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF ATTUNE TIBIAL COMPONENT AND INSERT DUE TO LOW GRADE INFECTION CAUSING LOOSENING IN THE TIBIA. SIZE 3, AFFIXIUM TIBIAL BASE PLATE WAS REMOVED AND REPLACED WITH A CEMENTED SIZE 3 RP TIBIAL BASE PLATE AND CR RP BEARING OF 12MM THICKNESS. DEBRIDEMENT AND WASHOUT WERE COMPLETED BEFORE REIMPLANTATION OCCURRED. THE FEMUR & PATELLA WERE BOTH LEFT IN-SITU AND WERE NOT REVISED. IMPLANTS REVISED: TIBIA & INSERT ONLY. FEMUR & PATELLA WERE LEFT INSITU. A WASHOUT WITH CHLORHEXIDINE WAS ALSO COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 24791141 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER KNEE REPLACEMENT BY DOCTOR ON (B)(6) 2025. PATIENT COMPLAINED OF LIMITED RANGE OF MOTION. SO, SURGEON PERFORMED A KNEE REVISION SURGERY TO IMPROVE HER RANGE OF MOTION ON (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 24743742 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE REPLACEMENT SURGERY ON (B)(6) 2025. THEY COMPLAINED OF LIMITED RANGE OF MOTION. SO, SURGEON PERFORMED A KNEE REVISION SURGERY TO IMPROVE RANGE OF MOTION ON (B)(6) 2026. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Loss of Range of Motion

  MAUDE report 24719246 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LAXITY IN THE KNEE. UPSIZED THE POLY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24603737 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR LINER EXCHANGE TO RULE OUT INFECTION. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23692152 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS REFERS TO A REVISION THAT TOOK PLACE IN AN INVESTIGATOR INITIATED CLINICAL STUDY (ATTUNE CEMENTLESS RSA STUDY). ONE PATIENT IN THIS STUDY RECENTLY UNDERWENT A FULL REVISION AT 11 MONTHS POST-OP. THE PATIENT HAD SWELLING AND PAIN UPON PRESENTATION TO THE CLINIC IN SEPTEMBER (UNSCHEDULED VISIT). AN INTERIM CT-RSA WAS PERFORMED WHICH SHOWED NO DISCERNIBLE MIGRATION OF THEIR TIBIAL TRAY, NO OBVIOUS MIGRATION THAT WOULD SUGGEST LOOSENING. THE PATIENT WAS REVISED ON (B)(6) 2025 FOR INFECTION (STAGE 1 OF 2-STAGE PROCEDURE). DR. PERFORMED THE REVISION AND NOTED THE 4 PERIPHERAL PEGS OF THE TRAY WERE SOLIDLY INGROWN.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23688559 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION AT 10 WEEK FOLLOW UP APPOINTMENT. KNEE WAS ASPIRATED AND CAME BACK POSITIVE FOR INFECTION. THE DOCTOR DECIDED TO EXPLANT THE TOTAL KNEE AND GAVE THE PATIENT A TEMPORARY ANTIBIOTIC SPACER UNTIL INFECTION IS CLEARED. ONCE INFECTION IS CLEARED, PATIENT WILL BE REVISED TO ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23301775 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS REMOVED DUE TO PAIN IN THE JOINT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22645671 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HYPEREXTENDED IN POST-OP. SURGEON CAME BACK FOR POLY-EXCHANGE. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22331599 ↗