AS VEGA System® PS NX036ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963810245), received between Jun 13, 2025 and Jun 13, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 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.

• InjuryJun 13, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE RIGHT KNEE FOR LOOSENING AND FAILURE OF PRIOR COMPONENTS. THE FEMORAL COMPONENT WAS REMOVED WITH MICRO-OSTEOTOME TECHNIQUES. THE TIBIA DEMONSTRATED MEDIAL-SIDED COLLAPSE AND WAS REAMED/BROACHED TO APPROPRIATE SIZE. TRIAL COMPONENTS WERE PLACED, AND STABLE FIXATION WITH ACCEPTABLE FLEXION/EXTENSION WAS ACHIEVED. FINAL FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED USING THIRD-GENERATION CEMENT TECHNIQUE. A POLYETHYLENE INSERT WAS PLACED, AND THE JOINT WAS COPIOUSLY IRRIGATED. THE PATIENT TOLERATED THE PROCEDURE, WAS AWAKENED FROM ANESTHESIA, AND TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 22205756 ↗