VEGA System® PS+ NX200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963811068), received between Apr 27, 2026 and Apr 27, 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.

• InjuryApr 27, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED ONGOING ISSUES FOLLOWING A LEFT KNEE PROSTHESIS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2021 FOR DEGENERATIVE JOINT DISEASE. THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. POSTOPERATIVELY, THE PATIENT INITIALLY REPORTED IMPROVEMENT, WITH FOLLOW-UP ON (B)(6), 2021 NOTING THAT THE PATIENT WAS DOING WELL WITH NO PAIN OR COMPLAINTS. HOWEVER, BY (B)(6), 2022, THE PATIENT REPORTED A FALL WITH SUBSEQUENT LEFT KNEE PAIN, DECREASED RANGE OF MOTION, AND LIGAMENTOUS INSTABILITY. IMAGING AND CLINICAL FINDINGS AT THAT TIME NOTED DEGENERATIVE CHANGES AND LAXITY. THE PATIENT CONTINUED TO REPORT PERSISTENT KNEE SYMPTOMS DESPITE CONSERVATIVE MANAGEMENT, INCLUDING INJECTIONS. BY (B)(6) 2022, THE PATIENT REPORTED ONGOING KNEE PAIN, THOUGH IMAGING DID NOT DEMONSTRATE LOOSENING AT THAT TIME. AT FOLLOW-UP ON (B)(6), 2026, IMAGING DEMONSTRATED A LEFT TOTAL KNEE PROSTHESIS IN PLACE WITH FINDINGS OF MECHANICAL LOOSENING OF THE FEMORAL COMPONENT, ASSOCIATED LUCENCY, AND INSTABILITY. CLINICAL EXAMINATION CONFIRMED LIGAMENTOUS LAXITY, EFFUSION, AND PAIN. DIAGNOSES INCLUDED MEC

  Patient problems: Failure of Implant

  MAUDE report 24999167 ↗