NEXGEN® 00-5886-064-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024310520), received between Oct 10, 2019 and Jul 27, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 12232670 ↗
• InjuryMay 6, 2020Unstable; Unstable

  NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Fall

  MAUDE report 10030316 ↗
• InjuryOct 10, 2019Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT HAD A LEFT TKA AND SUBSEQUENTLY COMPLAINS OF PAIN, INSTABILITY, ALTERED GAIT, AND ASPIRATION (RESULTS PENDING). THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Aspiration/Inhalation; Loss of Range of Motion; Pain; Swelling

  MAUDE report 9175757 ↗