NextAR Knee Platform 15.8010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630345731647), received between Aug 7, 2025 and Aug 7, 2025 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING TKA, THE TIBIAL INSERT TRIAL COULD NOT BE PROPERLY PLACED INTO THE INTENDED POSITION. UPON REVIEW BY THE SURGEON, IT WAS DETERMINED THAT THE CAUSE WAS MISALIGNMENT BETWEEN THE KEEL TRIAL AND THE TIBIAL TRAY TRIAL; THE KEEL TRIAL WAS NOT SEATED CORRECTLY. SEVERAL ATTEMPTS WERE MADE TO IMPACT THE KEEL TRIAL AND INSERT THE TIBIAL INSERT TRIAL, BUT THE ISSUE COULD NOT BE RESOLVED. AFTER REMOVING THE KEEL TRIAL AND VISUALLY INSPECTING THE INTRAMEDULLARY CANAL, IT WAS FOUND THAT THE NEXTAR TARGET HOLDER FIXATION PIN WAS INTERFERING WITH THE KEEL TRIAL. THE DEPTH OF THE FIXATION PIN WAS MANUALLY ADJUSTED UNTIL THE INTERFERENCE WAS ELIMINATED. THE SURGEYR WAS COMPLETED SUCCESSFULLY. THE TOTAL SURGERY TIME WAS 1 HOUR AND 45 MINUTES, AND THE DELAY TIME WAS 30 MINUTES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22737154 ↗