VEGA System® PS+ NX250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963811365), received between Sep 8, 2025 and Sep 8, 2025 — 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.

• InjurySep 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT PRESENTED WITH PAIN AND SWELLING OF THE LEFT KNEE. IMAGING DEMONSTRATED LOOSENING OF THE VEGA KNEE SYSTEM. ON (B)(6) 2025, THE PATIENT UNDERWENT REVISION TOTAL KNEE ARTHROPLASTY OF THE LEFT KNEE FOR LOOSENING OF PRIOR COMPONENTS. PREOPERATIVE EVALUATION INDICATED ASEPTIC LOOSENING; NO INFECTION WAS DETECTED. INTRAOPERATIVELY, THE TIBIAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE WITH NO CEMENT PRESENT ON ANY ASPECT OF THE IMPLANT. THE FEMORAL COMPONENT WAS ALSO LOOSE AND REMOVED EASILY WITH LIGHT TAPPING. THE PATELLAR COMPONENT WAS STABLE WITH NO EVIDENCE OF LOOSENING. FINDINGS WERE CONSISTENT WITH IMPLANT DEBONDING AT THE CEMENT INTERFACE. THE FEMUR AND TIBIA WERE PREPARED, AND REVISION FEMORAL AND TIBIAL COMPONENTS WERE IMPLANTED USING CEMENT FIXATION. A POLYETHYLENE INSERT AND MODULAR AUGMENTATION COMPONENTS WERE PLACED FOR STABILITY. AN ALLOGRAFT AND BONE CEMENT WERE ALSO UTILIZED. FINAL INSPECTION CONFIRMED STABLE FIXATION AND APPROPRIATE ALIGNMENT. THE WOUND WAS IRRIGATED, VANCOMYCIN POWDER WAS APPLIED, AND THE CAPSULE WAS CLOSED. THE PATIENT TOLERATED THE PROCEDURE AND WAS TRANSFERRED TO PACU IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 22994166 ↗