ATTUNE 1516-50-614Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295052623), received between Sep 3, 2020 and Jul 29, 2026 — classified as 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to Infected fracture.DOI: Unknown.DOR:(b)(6) 2026.Affected side: Right.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 50073196 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR INFECTION. DOI: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 21437852 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED LEFT TOTAL KNEE. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND POLY SWAP. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19340393 ↗
• InjuryJun 14, 2023Adverse 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 PAIN. THERE WAS NO LOOSENING AND IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17124803 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS RECURRENT BLEEDING IN HER KNEE. THERE WAS NO OBVIOUS SOURCE OF THE BLEEDING. BLOOD SENT FOR STUDY. I&D WITH POLY EXCHANGE ON RT TOTAL KNEE WAS PERFORMED. POLY THICKNESS INCREASED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10488652 ↗