ATTUNE 1518-20-407Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295541585), received between Mar 22, 2023 and Aug 18, 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.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient fell after original total knee arthroplasty, followed by a broken patella, surgical fixation of the patella, development of infection. Removal and replacement of all components except the patella was done and a SureSpace spacer was implanted. DOI: (b)(6), 2026DOR: (b)(6), 2026Affected Side: Left Knee

  Patient problems: Fall; Unspecified Infection

  MAUDE report 50310849 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY EXCHANGE DUE TO GLOBAL LAXITY. SIMPLY PUT IN A THICKER INSERT. NO FURTHER INFO AVAILABLE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25215885 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO TRAUMATIC FALL THAT RESULTED IN A TORN POSTERIOR CRUCIATE LIGAMENT (PCL). THE PATIENT, WHO HAD CR MS IMPLANTS, UNDERWENT UPSIZING OF THE INSERT. DOI: UNKNOWN, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 24575978 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT KNEE WAS INFECTED. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24099201 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA WAS REVISED DUE TO LACKED RANGE OF MOTION (ROM). REVISED THEY FIXED TIBIA AND REMOVED MORE TIBIA BONE. DOI: ON (B)(6) 2025, DOR: ON (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 23468014 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND BUSTED WOUND OPEN. NEEDED WASH OUT. NO SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 16591047 ↗