AS NR404ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963176549), received between Mar 23, 2026 and May 1, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Patient-Device Incompatibility

  A LAW FIRM REPORTS THAT A PATIENT ALLEGES POST-OPERATIVE LOOSENING OF AESCULAP KNEE IMPLANT. REPORTEDLY THERE WAS ALLEGED PAIN AND SWELLING 1 YEAR, 5 MONTHS POST OPERATIVE AFTER THE REVISION OF THE LEFT KNEE. THE ADVERSE EVENT IS FILED UNDER AIS REFERENCE: (B)(4).

  Patient problems: Implant Pain

  MAUDE report 25055811 ↗
• InjuryMar 23, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ISSUES FOLLOWING A LEFT KNEE PROSTHESIS THAT REQUIRED SUBSEQUENT MEDICAL INTERVENTION. ACCORDING TO THE OPERATIVE REPORT DATED (B)(6) 2022, A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. THE PROCEDURE WAS PERFORMED USING CEMENTED KNEE COMPONENTS (AESCULAP SYSTEM) WITH PALACOS BONE CEMENT. THE OPERATIVE REPORT INDICATES THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO INTRAOPERATIVE COMPLICATIONS, AND THE IMPLANTS WERE PLACED WITH APPROPRIATE ALIGNMENT AND STABILITY. ACCORDING TO A SUBSEQUENT OPERATIVE REPORT DATED (B)(6) 2023, THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. INTRAOPERATIVELY, BOTH COMPONENTS WERE NOTED TO BE GROSSLY LOOSE, WITH NO CEMENT ADHERENT TO THE IMPLANTS. THE COMPONENTS WERE REMOVED WITHOUT SIGNIFICANT BONE LOSS. REVISION WAS PERFORMED USING STEMMED FEMORAL AND TIBIAL COMPONENTS, BONE CEMENT, AND ADJUNCTIVE MATERIALS INCLUDING ANTIBIOTIC BEADS. FINAL IMPLANTATION DEMONSTRATED STABLE FIXATION WITH APPROPRIATE ALIGNMENT AND FULL RANGE OF MOTION WITHOUT INSTABILITY. THE PATIENT TOLERATED THE PROCEDURE AND W

  Patient problems: Failure of Implant

  MAUDE report 24661553 ↗