ATTUNE 1518-20-607Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295541745), received between Apr 11, 2024 and Jun 10, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATELLAR TENDON REPAIR WITH POLY EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25459926 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23018508 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ARTHROTOMY WITH LINER EXCHANGE WAS DONE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscle/Tendon Damage; Unspecified Musculoskeletal problem

  MAUDE report 21158089 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE DEVICE AND PROCEDURE(RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 19/SEP/24. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: : NO INFORMATION PROVIDED

  Patient problems: Pulmonary Embolism

  MAUDE report 20452357 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION WASHOUT AND POLY EXCHANGED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19536395 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION CONCERNS. POLY SWAP WAS PERFORMED PRIOR, 8 MONTHS AGO. ALL COMPONENTS REMOVED AND ALL POLY TIBIA AND METAL FEMUR WERE REIMPLANTED ALONG WITH ANTIBIOTIC BEADS. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE. RELATED TO (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19090635 ↗