AS NR179ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963176341), received between Mar 19, 2026 and Mar 19, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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.

• InjuryMar 19, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED FAILURE OF A RIGHT KNEE PROSTHESIS THAT REQUIRED REVISION SURGERY. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2025, THE PATIENT UNDERWENT REVISION ARTHROPLASTY OF THE RIGHT KNEE DUE TO A FAILED RIGHT TOTAL KNEE REPLACEMENT. THE OPERATIVE REPORT INDICATES THAT THE FEMORAL AND TIBIAL COMPONENTS WERE GROSSLY LOOSE, WITH MINIMAL CEMENT ADHERENCE NOTED. THE SURGEON DOCUMENTED A SUSPECTED CEMENT ADHESION ISSUE ASSOCIATED WITH THE PRIOR IMPLANT. THE EXISTING PROSTHETIC COMPONENTS WERE EASILY REMOVED WITH MINIMAL BONE LOSS. THE FEMUR AND TIBIA WERE PREPARED AND REVISION COMPONENTS WERE IMPLANTED USING BONE CEMENT. TRIALING REPORTEDLY DEMONSTRATED APPROPRIATE ALIGNMENT AND STABILITY THROUGH RANGE OF MOTION. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED IN THE OPERATIVE RECORD.

  Patient problems: Failure of Implant

  MAUDE report 24639442 ↗