AS NX063ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963810573), received between Mar 23, 2026 and Jun 30, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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.

• InjuryJun 30, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED COMPLICATIONS ASSOCIATED WITH A LEFT TOTAL KNEE REPLACEMENT (TKR). ACCORDING TO CLINICAL DOCUMENTATION, THE PATIENT UNDERWENT A REVISION LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2026 FOR A FAILED LEFT TOTAL KNEE REPLACEMENT WITH CHRONIC PAIN. OPERATIVE FINDINGS DOCUMENTED LOOSENING OF THE FEMORAL COMPONENT, WHICH WAS EASILY REMOVED FROM THE CEMENT MANTLE WITH NO BONDING ON THE POSTERIOR ASPECT OF THE FEMORAL PROSTHESIS. THE TIBIAL COMPONENT WAS ALSO REMOVED WITHOUT SIGNIFICANT DIFFICULTY OR BONE LOSS. THE PROCEDURE INVOLVED REMOVAL OF THE FAILED FEMORAL AND TIBIAL COMPONENTS AND IMPLANTATION OF ANOTHER MANUFACTURERS SYSTEM. NO INTRAOPERATIVE COMPLICATIONS WERE REPORTED. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 25664687 ↗
• 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 25055813 ↗
• 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 24661567 ↗