ATTUNE 1516-50-314Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295052203), received between Oct 25, 2022 and Jan 21, 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 18, 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.

• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMES IN TODAY FOR AN UNSTABLE TKA. DR REMOVED THE 3X14 RPPS AND UPSIZED TO A 3X18 RPPS TO REGAIN STABILITY. NO FURTHER PATIENT INFORMATION WAS AVAILABLE AT THIS TIME. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24134105 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED DUE TO INSTABILITY. THE PATIENT HAD A FALL AND SUBSEQUENTLY COMPLAINED THAT THE KNEE FELT UNSTABLE. ACCORDING TO THE SURGEON, THE INSTABILITY WAS NOT RELATED TO POLYETHYLENE WEAR. NO SURGICAL DELAY WAS REPORTED. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 21854816 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHOUT OF KNEE WAS PERFORMED DUE TO UNKNOWN REASON. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17940842 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP WAS NEEDED. DOI: UNKNOWN. DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15665907 ↗