VEGA System® PS+ NX211Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963811136), received between Mar 13, 2026 and May 19, 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 19, 2026Patient-Device Incompatibility

  AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED POSTOPERATIVE LOOSENING. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT, WITH A HISTORY OF RIGHT KNEE DEGENERATIVE JOINT DISEASE, UNDERWENT A RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2022. THE PROCEDURE WAS COMPLETED WITHOUT INTRAOPERATIVE COMPLICATIONS. A SUBSEQUENT CLINIC NOTE DATED (B)(6) 2025 INDICATES THAT THE PATIENT CONTINUED TO EXPERIENCE SYMPTOMS AND WOULD LIKELY REQUIRE FURTHER KNEE REPLACEMENT INTERVENTION. THIS REPORT IS FILED UNDER AIS REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 25217829 ↗
• InjuryMar 13, 2026Patient-Device Incompatibility

  AN ADVERSE EVENT WAS REPORTED INVOLVING AN UNKNOWN AESCULAP AG KNEE IMPLANT SYSTEM. SPECIFICALLY, AN OUTSIDE LAW FIRM REPORTED THAT A PATIENT EXPERIENCED POSTOPERATIVE LOOSENING. PATIENT UNDERWENT A REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 24589674 ↗